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INREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-us LOCATIONS & CONTACT INFORMATION Toledo (Global Headquarters) 6750 Wales Road. Northwood, Ohio, USA 43619. Office: +1-866-666-9455 (toll free) Office: +1-419-666-9455 (outside of USA) Get Directions. CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. EU COMMISSION UPDATE : NOTIFIED BODIES DESIGNATED TO MDR Update. As of 10 July 2020, there are 15 Notified Bodies designated to MDR and four (4) designated to IVDR, with at least nine (9) additional NBs pending designation. To date, 44 MDR and 11 IVDR applications have been received, recently reported by the EU Commission. The current list of designated Notified Bodies is included below. BIOLOGICAL SAFETY TRAINING Join NAMSA as we launch our NEW virtual Biocompatibility of Medical Devices Training on June 8-9, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.). Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. NAMSA’S GLP AND GMP GUIDE 6 NAMSA’s GLP and GMP Guide GLP Pharmaceutical GMP Lot Release Medical Device QSR GMP Lot Release GMP In-Process Testing Other Documents Protocol – Each study requires a protocol, RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. INDUCTIVELY COUPLED PLASMA MASS SPECTROSCOPY (ICP-MS Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Full Scan – is a quantitative analysis that looks for about 46 different inorganic/metallic elements that could extract from the material. These may be related to additives, colorants, etc. used in the device. NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT May 11, 2021. Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership. NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-us LOCATIONS & CONTACT INFORMATION Toledo (Global Headquarters) 6750 Wales Road. Northwood, Ohio, USA 43619. Office: +1-866-666-9455 (toll free) Office: +1-419-666-9455 (outside of USA) Get Directions. CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. EU COMMISSION UPDATE : NOTIFIED BODIES DESIGNATED TO MDR Update. As of 10 July 2020, there are 15 Notified Bodies designated to MDR and four (4) designated to IVDR, with at least nine (9) additional NBs pending designation. To date, 44 MDR and 11 IVDR applications have been received, recently reported by the EU Commission. The current list of designated Notified Bodies is included below. BIOLOGICAL SAFETY TRAINING Join NAMSA as we launch our NEW virtual Biocompatibility of Medical Devices Training on June 8-9, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.). Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. NAMSA’S GLP AND GMP GUIDE 6 NAMSA’s GLP and GMP Guide GLP Pharmaceutical GMP Lot Release Medical Device QSR GMP Lot Release GMP In-Process Testing Other Documents Protocol – Each study requires a protocol, RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. INDUCTIVELY COUPLED PLASMA MASS SPECTROSCOPY (ICP-MS Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Full Scan – is a quantitative analysis that looks for about 46 different inorganic/metallic elements that could extract from the material. These may be related to additives, colorants, etc. used in the device.TESTS | NAMSA
Looking for Client Portal? Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Go to ClientPortal
OUR HISTORY
developing & delivering novel medical device technologies since 1967. In 1967, a glass manufacturer in Toledo, Ohio approached a clinical laboratory to test polymeric materials for pharmaceutical container testing. While the clinical lab passed on the work, Dr. Theodore Gorski, a scientist-entrepreneur, recognized the opportunity andaccepted
WEBSITE ACCESSIBILITY STATEMENT WEBSITE ACCESSIBILITY STATEMENT . Updated as of June 11, 2021. This Accessibility Statement is provided by NAMSA (hereinafter referred to as “NAMSA” “we”, “our” “us”). GENERAL SURGERY EXPERTISE NAMSA is proud to have worked with leading general and plastic surgery manufacturers throughout the globe by offering proven, results-oriented development services. MDR TRANSITION TIMELINES FOR LEGACY MEDICAL DEVICES CE-Marked legacy devices have a maximum of five (5) more years to transition, assuming they are manufactured, packaged, labeled and released into a finished goods warehouse before the transition end date of June 2020 (DoA). This assumes a valid MDD/AIMD certificate that expires post-release into finished goods. CARDIOLOGY EXPERTISE In addition to thousands of cardiovascular biological safety tests conducted annually, NAMSA has completed over 500 customized preclinical studies worldwide. NAMSA supports over 300 cardiology projects and clinical trials per year, and on average, 40 percent of our clinical studies supported involve cardiology or peripheral vascular devices, including: RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. IVDR TECHNICAL DOCUMENTATION: 5 CRITICAL PARAMETERS OF IVDR obligations for manufacturers are to demonstrate the following in the device documentation: Analytical performance. Clinical performance. Scientific Validity. Stability. Additionally, clinical evidence is based on data surrounding Scientific Validity, Analytical Performance and Clinical Performance of the device. NAMSA ACQUIRES AMERICAN PRECLINICAL SERVICES NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of Minneapolis-based American Preclinical Services (APS), a full service preclinical CRO. This purchase follows NAMSA’s acquisition of New York-based Syntactx, a leading clinical research services CRO, in January 2021. NAMSA ELEARNING ISO 10993 SERIES 1 Price. $ 1,625.00. In the 22 parts of this standard, various biological safety endpoints are described and prescribed for evaluation based on a medical device contact type and duration. An evaluation strategy is developed specific to material, device contact, and contact duration; allowing manufacturers to produce devices thatare safe for
NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT May 11, 2021. Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership. NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-usTESTS | NAMSA
Looking for Client Portal? Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Go to ClientPortal
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. BIOLOGICAL SAFETY TRAINING Join NAMSA as we launch our NEW virtual Biocompatibility of Medical Devices Training on June 8-9, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.). Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT May 11, 2021. Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership. NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-usTESTS | NAMSA
Looking for Client Portal? Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Go to ClientPortal
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. BIOLOGICAL SAFETY TRAINING Join NAMSA as we launch our NEW virtual Biocompatibility of Medical Devices Training on June 8-9, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.). Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office.ABOUT OUR COMPANY
“The results that NAMSA’s expert testing, clinical and consulting teams delivered to our organization were truly exceptional. Not only did NAMSA’s deep-rooted and extensive experience with the U.S. FDA allow us to achieve unparalleled, accelerated results, but their consistency, responsiveness and proactive nature were also key factorsin our success.
TESTS | NAMSA
Looking for Client Portal? Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Go to ClientPortal
ACCREDITATIONS & CERTIFICATIONS NAMSA is certified to ISO 9001:2015, and is accredited to ISO/IEC 17025:2017. NAMSA is committed, through our internal audit and management review processes, to ensuring continued compliance with all relevant regulatory and statutory requirements including MEDICAL DEVICE CLINICAL RESEARCH Leveraging NAMSA’s vast knowledge and expertise in medical devices, our Biostatisticians capture, analyze and present data from clinical trials to provide the clinical support and evidence you need to be successful. With an average of 15 years’ experience, each team member is 100% medical device-focused and understands the nuances and GENERAL SURGERY EXPERTISE NAMSA is proud to have worked with leading general and plastic surgery manufacturers throughout the globe by offering proven, results-oriented development services. WEBSITE ACCESSIBILITY STATEMENT WEBSITE ACCESSIBILITY STATEMENT . Updated as of June 11, 2021. This Accessibility Statement is provided by NAMSA (hereinafter referred to as “NAMSA” “we”, “our” “us”). THREE ESSENTIALS FOR SMART IVD CLINICAL TRIAL DESIGN Categories: Clinical , IVD. When designing an In Vitro Diagnostic (IVD) clinical trial, there are three major areas that must be considered if manufacturers are to achieve optimal, accurate outcomes: Biostatistics. Clinical research conduct. Data management. While these three clinical research disciplines are interdependent on one other,equal
CARDIOLOGY EXPERTISE In addition to thousands of cardiovascular biological safety tests conducted annually, NAMSA has completed over 500 customized preclinical studies worldwide. NAMSA supports over 300 cardiology projects and clinical trials per year, and on average, 40 percent of our clinical studies supported involve cardiology or peripheral vascular devices, including: USP MUSCLE IMPLANTATION STUDY Standards. United States Pharmacopeia. ISO 10993-6. Implantation tests are performed to evaluate the local d pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical Implantation tests are performed to evaluate the local pathological effects on living tissue, at both the HOW TO IMPLEMENT AN EFFECTIVE INTERNAL AUDIT PROGRAM An organization’s internal audit program is more than meeting the requirements of the 21 CFR 820, ISO 13485 or ISO 9001 standards. An effective internal audit program is an essential part of an effective Quality Management System (QMS), and can be a key communication tool in the promotion of continual improvement throughout the organization NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT May 11, 2021. Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership. NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-usTESTS | NAMSA
Looking for Client Portal? Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Go to ClientPortal
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and ACCREDITATIONS & CERTIFICATIONS REGULATORY REQUIREMENTS AND QUALITY IN OPERATIONS. NAMSA is certified to ISO 9001:2015, and is accredited to ISO/IEC 17025:2017. NAMSA is committed, through our internal audit and management review processes, to ensuring continued compliance with all relevant regulatory and statutory requirements including but not limited to ISO 13485:2016 BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT May 11, 2021. Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership. NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-usTESTS | NAMSA
Looking for Client Portal? Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Go to ClientPortal
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and ACCREDITATIONS & CERTIFICATIONS REGULATORY REQUIREMENTS AND QUALITY IN OPERATIONS. NAMSA is certified to ISO 9001:2015, and is accredited to ISO/IEC 17025:2017. NAMSA is committed, through our internal audit and management review processes, to ensuring continued compliance with all relevant regulatory and statutory requirements including but not limited to ISO 13485:2016 BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office.ABOUT OUR COMPANY
“The results that NAMSA’s expert testing, clinical and consulting teams delivered to our organization were truly exceptional. Not only did NAMSA’s deep-rooted and extensive experience with the U.S. FDA allow us to achieve unparalleled, accelerated results, but their consistency, responsiveness and proactive nature were also key factorsin our success.
TESTS | NAMSA
Looking for Client Portal? Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Go to ClientPortal
OUR VALUES | NAMSA
OUR VALUES. Since 1967, NAMSA has grown, but the values that defined us from the start are those that still guide us today. NAMSA’s modest roots in medical device laboratory operations in the 1960s and 1970s have evolved to help clients develop and deliver innovativemedical products in
ACCREDITATIONS & CERTIFICATIONS REGULATORY REQUIREMENTS AND QUALITY IN OPERATIONS. NAMSA is certified to ISO 9001:2015, and is accredited to ISO/IEC 17025:2017. NAMSA is committed, through our internal audit and management review processes, to ensuring continued compliance with all relevant regulatory and statutory requirements including but not limited to ISO 13485:2016 FDA BREAKTHROUGH DEVICES AND SAFER TECHNOLOGIES PROGRAMS Medical device and diagnostic manufacturers seeking acceleration of U.S. Food and Drug Administration (FDA) approval may benefit from one of two purpose-built FDA programs: 1) the Breakthrough Devices Program; and 2) the Safer Technologies Program (STeP). The benefits of these programs are substantial for manufacturers who apply, qualify and are granted designation by FDA. ARCHIMED ACQUIRES MAJORITY INTEREST IN NAMSA NAMSA is the third acquisition of ArchiMed’s recently closed €1 billion ($1.2 billion) MED Platform I buy-and-build fund. MED Platform I partners with growth companies in the European and North American mid-cap healthcare sectors, buying majority stakes for €50 million to €500 million in association with existing owners and managers. USP MUSCLE IMPLANTATION STUDY Standards. United States Pharmacopeia. ISO 10993-6. Implantation tests are performed to evaluate the local d pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical Implantation tests are performed to evaluate the local pathological effects on living tissue, at both the BIOCOMPATIBILITY EXTRACTIONS: THE HOW AND WHY All of this and more are answered in this episode of Biocomp CHAT ibility. “If you are looking at the biocompatibility testing, the concept of extractions is going to come up eventually. Basically, trying to get something that we can dose into a study, whatever study that you are doing. If you are trying to simulate what the human bodymay
ISO INTRACUTANEOUS STUDY ISO 10993-10. Irritation tests are utilized to assess the irritation potential of medical devices, bio-materials, or their extracts exposed to eye, skin, or mucous membranes. The test (s) are performed using a model appropriate for the route (skin, eye, mucosa) and duration of exposure or contact. CYTOTOXICITY STUDY USING THE USP AGAR DIFFUSION METHOD Standards. ISO 10993-5. Cytotoxicity tests are used to determine the lysis (death) of cells, colony formation, inhibition of cell growth, and or other effects on cells caused by medical devices, bio-materials, or their extracts utilizing cell culture techniques. NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT The world's only 100% medical device-focused, full development Contract Research Organization (CRO). Learn how to accelerate your development program today! NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-usTESTS | NAMSA
Looking for Client Portal? Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Go to ClientPortal
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT The world's only 100% medical device-focused, full development Contract Research Organization (CRO). Learn how to accelerate your development program today! NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-usTESTS | NAMSA
Looking for Client Portal? Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Go to ClientPortal
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office.ABOUT OUR COMPANY
“The results that NAMSA’s expert testing, clinical and consulting teams delivered to our organization were truly exceptional. Not only did NAMSA’s deep-rooted and extensive experience with the U.S. FDA allow us to achieve unparalleled, accelerated results, but their consistency, responsiveness and proactive nature were also key factorsin our success.
TESTS | NAMSA
Looking for Client Portal? Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Go to ClientPortal
ACCREDITATIONS & CERTIFICATIONS NAMSA is certified to ISO 9001:2015, accredited to ISO/IEC 17025:2017, and committed to ensuring continued regulatory and statuatorycompliance.
FDA BREAKTHROUGH DEVICES AND SAFER TECHNOLOGIES PROGRAMS Medical device and diagnostic manufacturers seeking acceleration of U.S. Food and Drug Administration (FDA) approval may benefit from one of two purpose-built FDA programs: 1) the Breakthrough Devices Program; and 2) the Safer Technologies Program (STeP). The benefits of these programs are substantial for manufacturers who apply, qualify and are granted designation by FDA.STEAM STERILIZATION
This test is selected when a sample needs to be exposed to steam prior to being used in testing. The sample can be exposed to a validated NAMSA dry good cycle or ISO INTRACUTANEOUS STUDY TI251-800: Extract: TI251-804: ISO Modified Intracutaneous Study - Solution: TI251-805: Extract Retest: TI251-84S: ISO Modified Intracutaneous Study - Solution with Measurement ARCHIMED ACQUIRES MAJORITY INTEREST IN NAMSA Leah Davidson, MA, MBA. Leah has been with NAMSA since 2016 and currently serves as Senior Manager of Global Marketing Communications. She possesses 20 years' experience within the medical device, healthcare technology and non-profit industries and has worked in various marketing and communications capacities throughout her career. USP MUSCLE IMPLANTATION STUDY Implantation tests are performed to evaluate the local d pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical Implantation tests are performed to evaluate the local pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical devices or bio-materials. CYTOTOXICITY STUDY USING THE USP AGAR DIFFUSION METHOD Cytotoxicity tests are used to determine the lysis (death) of cells, colony formation, inhibition of cell growth, and or other effects on cells caused by medical devices, bio-materials, or their extracts utilizing cell culture techniques BIOCOMPATIBILITY EXTRACTIONS: THE HOW AND WHY Extractions: The How and Why . There are many mentions of extractions in medical device testing. In this episode, our hosts discuss ISO 10993-12 for sample preparations and extraction conditions. NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT May 11, 2021. Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership. NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-us LOCATIONS & CONTACT INFORMATION Toledo (Global Headquarters) 6750 Wales Road. Northwood, Ohio, USA 43619. Office: +1-866-666-9455 (toll free) Office: +1-419-666-9455 (outside of USA) Get Directions. MEDICAL DEVICE TESTING NAMSA PIONEERED THE MEDICAL DEVICE TESTING INDUSTRY. Established in 1967, NAMSA is the pioneer of the medical device testing industry and continues to serve as the global marketplace leader for reliable, proven testing services. On an annual basis, our teams conduct over 100,000 tests across our state-of-the-art laboratories across theglobe.
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. EU COMMISSION UPDATE : NOTIFIED BODIES DESIGNATED TO MDR Update. As of 10 July 2020, there are 15 Notified Bodies designated to MDR and four (4) designated to IVDR, with at least nine (9) additional NBs pending designation. To date, 44 MDR and 11 IVDR applications have been received, recently reported by the EU Commission. The current list of designated Notified Bodies is included below. RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. USP MUSCLE IMPLANTATION STUDY Standards. United States Pharmacopeia. ISO 10993-6. Implantation tests are performed to evaluate the local d pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical Implantation tests are performed to evaluate the local pathological effects on living tissue, at both the INDUCTIVELY COUPLED PLASMA MASS SPECTROSCOPY (ICP-MS Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Full Scan – is a quantitative analysis that looks for about 46 different inorganic/metallic elements that could extract from the material. These may be related to additives, colorants, etc. used in the device. NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT May 11, 2021. Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership. NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-us LOCATIONS & CONTACT INFORMATION Toledo (Global Headquarters) 6750 Wales Road. Northwood, Ohio, USA 43619. Office: +1-866-666-9455 (toll free) Office: +1-419-666-9455 (outside of USA) Get Directions. MEDICAL DEVICE TESTING NAMSA PIONEERED THE MEDICAL DEVICE TESTING INDUSTRY. Established in 1967, NAMSA is the pioneer of the medical device testing industry and continues to serve as the global marketplace leader for reliable, proven testing services. On an annual basis, our teams conduct over 100,000 tests across our state-of-the-art laboratories across theglobe.
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. EU COMMISSION UPDATE : NOTIFIED BODIES DESIGNATED TO MDR Update. As of 10 July 2020, there are 15 Notified Bodies designated to MDR and four (4) designated to IVDR, with at least nine (9) additional NBs pending designation. To date, 44 MDR and 11 IVDR applications have been received, recently reported by the EU Commission. The current list of designated Notified Bodies is included below. RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. USP MUSCLE IMPLANTATION STUDY Standards. United States Pharmacopeia. ISO 10993-6. Implantation tests are performed to evaluate the local d pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical Implantation tests are performed to evaluate the local pathological effects on living tissue, at both the INDUCTIVELY COUPLED PLASMA MASS SPECTROSCOPY (ICP-MS Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Full Scan – is a quantitative analysis that looks for about 46 different inorganic/metallic elements that could extract from the material. These may be related to additives, colorants, etc. used in the device.ABOUT OUR COMPANY
“The results that NAMSA’s expert testing, clinical and consulting teams delivered to our organization were truly exceptional. Not only did NAMSA’s deep-rooted and extensive experience with the U.S. FDA allow us to achieve unparalleled, accelerated results, but their consistency, responsiveness and proactive nature were also key factorsin our success.
TESTS | NAMSA
Looking for Client Portal? Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Go to ClientPortal
CAREERS | NAMSA
Just a few of NAMSA’s benefits include: A variety of Medical, Dental and Vision programs. 401 (k) program with company match. Annual bonus incentive. Tuition, training and certification reimbursement. Paid holidays and vacation time. Relocation services. Employee assistance programs. Career development and advancement opportunities.OUR VALUES | NAMSA
OUR VALUES. Since 1967, NAMSA has grown, but the values that defined us from the start are those that still guide us today. NAMSA’s modest roots in medical device laboratory operations in the 1960s and 1970s have evolved to help clients develop and deliver innovativemedical products in
FDA BREAKTHROUGH DEVICES AND SAFER TECHNOLOGIES PROGRAMS Medical device and diagnostic manufacturers seeking acceleration of U.S. Food and Drug Administration (FDA) approval may benefit from one of two purpose-built FDA programs: 1) the Breakthrough Devices Program; and 2) the Safer Technologies Program (STeP). The benefits of these programs are substantial for manufacturers who apply, qualify and are granted designation by FDA. RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. NAMSA ELEARNING ISO 10993 SERIES 1 Price. $ 1,625.00. In the 22 parts of this standard, various biological safety endpoints are described and prescribed for evaluation based on a medical device contact type and duration. An evaluation strategy is developed specific to material, device contact, and contact duration; allowing manufacturers to produce devices thatare safe for
ISO INTRACUTANEOUS STUDY ISO 10993-10. Irritation tests are utilized to assess the irritation potential of medical devices, bio-materials, or their extracts exposed to eye, skin, or mucous membranes. The test (s) are performed using a model appropriate for the route (skin, eye, mucosa) and duration of exposure or contact. BIOCOMPATIBILITY EXTRACTIONS: THE HOW AND WHY All of this and more are answered in this episode of Biocomp CHAT ibility. “If you are looking at the biocompatibility testing, the concept of extractions is going to come up eventually. Basically, trying to get something that we can dose into a study, whatever study that you are doing. If you are trying to simulate what the human bodymay
CYTOTOXICITY STUDY USING THE USP AGAR DIFFUSION METHOD Standards. ISO 10993-5. Cytotoxicity tests are used to determine the lysis (death) of cells, colony formation, inhibition of cell growth, and or other effects on cells caused by medical devices, bio-materials, or their extracts utilizing cell culture techniques. NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT May 11, 2021. Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership. NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-us LOCATIONS & CONTACT INFORMATION Toledo (Global Headquarters) 6750 Wales Road. Northwood, Ohio, USA 43619. Office: +1-866-666-9455 (toll free) Office: +1-419-666-9455 (outside of USA) Get Directions. MEDICAL DEVICE TESTING NAMSA PIONEERED THE MEDICAL DEVICE TESTING INDUSTRY. Established in 1967, NAMSA is the pioneer of the medical device testing industry and continues to serve as the global marketplace leader for reliable, proven testing services. On an annual basis, our teams conduct over 100,000 tests across our state-of-the-art laboratories across theglobe.
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. EU COMMISSION UPDATE : NOTIFIED BODIES DESIGNATED TO MDR Update. As of 10 July 2020, there are 15 Notified Bodies designated to MDR and four (4) designated to IVDR, with at least nine (9) additional NBs pending designation. To date, 44 MDR and 11 IVDR applications have been received, recently reported by the EU Commission. The current list of designated Notified Bodies is included below. RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. USP MUSCLE IMPLANTATION STUDY Standards. United States Pharmacopeia. ISO 10993-6. Implantation tests are performed to evaluate the local d pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical Implantation tests are performed to evaluate the local pathological effects on living tissue, at both the INDUCTIVELY COUPLED PLASMA MASS SPECTROSCOPY (ICP-MS Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Full Scan – is a quantitative analysis that looks for about 46 different inorganic/metallic elements that could extract from the material. These may be related to additives, colorants, etc. used in the device. NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT May 11, 2021. Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership. NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-us LOCATIONS & CONTACT INFORMATION Toledo (Global Headquarters) 6750 Wales Road. Northwood, Ohio, USA 43619. Office: +1-866-666-9455 (toll free) Office: +1-419-666-9455 (outside of USA) Get Directions. MEDICAL DEVICE TESTING NAMSA PIONEERED THE MEDICAL DEVICE TESTING INDUSTRY. Established in 1967, NAMSA is the pioneer of the medical device testing industry and continues to serve as the global marketplace leader for reliable, proven testing services. On an annual basis, our teams conduct over 100,000 tests across our state-of-the-art laboratories across theglobe.
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. EU COMMISSION UPDATE : NOTIFIED BODIES DESIGNATED TO MDR Update. As of 10 July 2020, there are 15 Notified Bodies designated to MDR and four (4) designated to IVDR, with at least nine (9) additional NBs pending designation. To date, 44 MDR and 11 IVDR applications have been received, recently reported by the EU Commission. The current list of designated Notified Bodies is included below. RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. USP MUSCLE IMPLANTATION STUDY Standards. United States Pharmacopeia. ISO 10993-6. Implantation tests are performed to evaluate the local d pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical Implantation tests are performed to evaluate the local pathological effects on living tissue, at both the INDUCTIVELY COUPLED PLASMA MASS SPECTROSCOPY (ICP-MS Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Full Scan – is a quantitative analysis that looks for about 46 different inorganic/metallic elements that could extract from the material. These may be related to additives, colorants, etc. used in the device.ABOUT OUR COMPANY
“The results that NAMSA’s expert testing, clinical and consulting teams delivered to our organization were truly exceptional. Not only did NAMSA’s deep-rooted and extensive experience with the U.S. FDA allow us to achieve unparalleled, accelerated results, but their consistency, responsiveness and proactive nature were also key factorsin our success.
TESTS | NAMSA
Looking for Client Portal? Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Go to ClientPortal
CAREERS | NAMSA
Just a few of NAMSA’s benefits include: A variety of Medical, Dental and Vision programs. 401 (k) program with company match. Annual bonus incentive. Tuition, training and certification reimbursement. Paid holidays and vacation time. Relocation services. Employee assistance programs. Career development and advancement opportunities.OUR VALUES | NAMSA
OUR VALUES. Since 1967, NAMSA has grown, but the values that defined us from the start are those that still guide us today. NAMSA’s modest roots in medical device laboratory operations in the 1960s and 1970s have evolved to help clients develop and deliver innovativemedical products in
FDA BREAKTHROUGH DEVICES AND SAFER TECHNOLOGIES PROGRAMS Medical device and diagnostic manufacturers seeking acceleration of U.S. Food and Drug Administration (FDA) approval may benefit from one of two purpose-built FDA programs: 1) the Breakthrough Devices Program; and 2) the Safer Technologies Program (STeP). The benefits of these programs are substantial for manufacturers who apply, qualify and are granted designation by FDA. RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. NAMSA ELEARNING ISO 10993 SERIES 1 Price. $ 1,625.00. In the 22 parts of this standard, various biological safety endpoints are described and prescribed for evaluation based on a medical device contact type and duration. An evaluation strategy is developed specific to material, device contact, and contact duration; allowing manufacturers to produce devices thatare safe for
ISO INTRACUTANEOUS STUDY ISO 10993-10. Irritation tests are utilized to assess the irritation potential of medical devices, bio-materials, or their extracts exposed to eye, skin, or mucous membranes. The test (s) are performed using a model appropriate for the route (skin, eye, mucosa) and duration of exposure or contact. BIOCOMPATIBILITY EXTRACTIONS: THE HOW AND WHY All of this and more are answered in this episode of Biocomp CHAT ibility. “If you are looking at the biocompatibility testing, the concept of extractions is going to come up eventually. Basically, trying to get something that we can dose into a study, whatever study that you are doing. If you are trying to simulate what the human bodymay
CYTOTOXICITY STUDY USING THE USP AGAR DIFFUSION METHOD Standards. ISO 10993-5. Cytotoxicity tests are used to determine the lysis (death) of cells, colony formation, inhibition of cell growth, and or other effects on cells caused by medical devices, bio-materials, or their extracts utilizing cell culture techniques. NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT May 11, 2021. Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership. NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-us LOCATIONS & CONTACT INFORMATION Toledo (Global Headquarters) 6750 Wales Road. Northwood, Ohio, USA 43619. Office: +1-866-666-9455 (toll free) Office: +1-419-666-9455 (outside of USA) Get Directions. MEDICAL DEVICE TESTING NAMSA PIONEERED THE MEDICAL DEVICE TESTING INDUSTRY. Established in 1967, NAMSA is the pioneer of the medical device testing industry and continues to serve as the global marketplace leader for reliable, proven testing services. On an annual basis, our teams conduct over 100,000 tests across our state-of-the-art laboratories across theglobe.
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. EU COMMISSION UPDATE : NOTIFIED BODIES DESIGNATED TO MDR Update. As of 10 July 2020, there are 15 Notified Bodies designated to MDR and four (4) designated to IVDR, with at least nine (9) additional NBs pending designation. To date, 44 MDR and 11 IVDR applications have been received, recently reported by the EU Commission. The current list of designated Notified Bodies is included below. RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. USP MUSCLE IMPLANTATION STUDY Standards. United States Pharmacopeia. ISO 10993-6. Implantation tests are performed to evaluate the local d pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical Implantation tests are performed to evaluate the local pathological effects on living tissue, at both the INDUCTIVELY COUPLED PLASMA MASS SPECTROSCOPY (ICP-MS Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Full Scan – is a quantitative analysis that looks for about 46 different inorganic/metallic elements that could extract from the material. These may be related to additives, colorants, etc. used in the device. NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT May 11, 2021. Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership. NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-us LOCATIONS & CONTACT INFORMATION Toledo (Global Headquarters) 6750 Wales Road. Northwood, Ohio, USA 43619. Office: +1-866-666-9455 (toll free) Office: +1-419-666-9455 (outside of USA) Get Directions. MEDICAL DEVICE TESTING NAMSA PIONEERED THE MEDICAL DEVICE TESTING INDUSTRY. Established in 1967, NAMSA is the pioneer of the medical device testing industry and continues to serve as the global marketplace leader for reliable, proven testing services. On an annual basis, our teams conduct over 100,000 tests across our state-of-the-art laboratories across theglobe.
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. EU COMMISSION UPDATE : NOTIFIED BODIES DESIGNATED TO MDR Update. As of 10 July 2020, there are 15 Notified Bodies designated to MDR and four (4) designated to IVDR, with at least nine (9) additional NBs pending designation. To date, 44 MDR and 11 IVDR applications have been received, recently reported by the EU Commission. The current list of designated Notified Bodies is included below. RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. USP MUSCLE IMPLANTATION STUDY Standards. United States Pharmacopeia. ISO 10993-6. Implantation tests are performed to evaluate the local d pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical Implantation tests are performed to evaluate the local pathological effects on living tissue, at both the INDUCTIVELY COUPLED PLASMA MASS SPECTROSCOPY (ICP-MS Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Full Scan – is a quantitative analysis that looks for about 46 different inorganic/metallic elements that could extract from the material. These may be related to additives, colorants, etc. used in the device.ABOUT OUR COMPANY
“The results that NAMSA’s expert testing, clinical and consulting teams delivered to our organization were truly exceptional. Not only did NAMSA’s deep-rooted and extensive experience with the U.S. FDA allow us to achieve unparalleled, accelerated results, but their consistency, responsiveness and proactive nature were also key factorsin our success.
TESTS | NAMSA
Looking for Client Portal? Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. Go to ClientPortal
CAREERS | NAMSA
Just a few of NAMSA’s benefits include: A variety of Medical, Dental and Vision programs. 401 (k) program with company match. Annual bonus incentive. Tuition, training and certification reimbursement. Paid holidays and vacation time. Relocation services. Employee assistance programs. Career development and advancement opportunities.OUR VALUES | NAMSA
OUR VALUES. Since 1967, NAMSA has grown, but the values that defined us from the start are those that still guide us today. NAMSA’s modest roots in medical device laboratory operations in the 1960s and 1970s have evolved to help clients develop and deliver innovativemedical products in
FDA BREAKTHROUGH DEVICES AND SAFER TECHNOLOGIES PROGRAMS Medical device and diagnostic manufacturers seeking acceleration of U.S. Food and Drug Administration (FDA) approval may benefit from one of two purpose-built FDA programs: 1) the Breakthrough Devices Program; and 2) the Safer Technologies Program (STeP). The benefits of these programs are substantial for manufacturers who apply, qualify and are granted designation by FDA. RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. NAMSA ELEARNING ISO 10993 SERIES 1 Price. $ 1,625.00. In the 22 parts of this standard, various biological safety endpoints are described and prescribed for evaluation based on a medical device contact type and duration. An evaluation strategy is developed specific to material, device contact, and contact duration; allowing manufacturers to produce devices thatare safe for
ISO INTRACUTANEOUS STUDY ISO 10993-10. Irritation tests are utilized to assess the irritation potential of medical devices, bio-materials, or their extracts exposed to eye, skin, or mucous membranes. The test (s) are performed using a model appropriate for the route (skin, eye, mucosa) and duration of exposure or contact. BIOCOMPATIBILITY EXTRACTIONS: THE HOW AND WHY All of this and more are answered in this episode of Biocomp CHAT ibility. “If you are looking at the biocompatibility testing, the concept of extractions is going to come up eventually. Basically, trying to get something that we can dose into a study, whatever study that you are doing. If you are trying to simulate what the human bodymay
CYTOTOXICITY STUDY USING THE USP AGAR DIFFUSION METHOD Standards. ISO 10993-5. Cytotoxicity tests are used to determine the lysis (death) of cells, colony formation, inhibition of cell growth, and or other effects on cells caused by medical devices, bio-materials, or their extracts utilizing cell culture techniques. NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT May 11, 2021. Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership. NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-us LOCATIONS & CONTACT INFORMATION Toledo (Global Headquarters) 6750 Wales Road. Northwood, Ohio, USA 43619. Office: +1-866-666-9455 (toll free) Office: +1-419-666-9455 (outside of USA) Get Directions. MEDICAL DEVICE TESTING NAMSA PIONEERED THE MEDICAL DEVICE TESTING INDUSTRY. Established in 1967, NAMSA is the pioneer of the medical device testing industry and continues to serve as the global marketplace leader for reliable, proven testing services. On an annual basis, our teams conduct over 100,000 tests across our state-of-the-art laboratories across theglobe.
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. EU COMMISSION UPDATE : NOTIFIED BODIES DESIGNATED TO MDR Update. As of 10 July 2020, there are 15 Notified Bodies designated to MDR and four (4) designated to IVDR, with at least nine (9) additional NBs pending designation. To date, 44 MDR and 11 IVDR applications have been received, recently reported by the EU Commission. The current list of designated Notified Bodies is included below. RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. USP MUSCLE IMPLANTATION STUDY Standards. United States Pharmacopeia. ISO 10993-6. Implantation tests are performed to evaluate the local d pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical Implantation tests are performed to evaluate the local pathological effects on living tissue, at both the INDUCTIVELY COUPLED PLASMA MASS SPECTROSCOPY (ICP-MS Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Full Scan – is a quantitative analysis that looks for about 46 different inorganic/metallic elements that could extract from the material. These may be related to additives, colorants, etc. used in the device. NAMSA | CONTRACT RESEARCH ORGANIZATION FOR MEDICAL DEVICESSIGN INSERVICESRESOURCESEVENTSABOUTLOCATIONS & CONTACT May 11, 2021. Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership. NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in NAMSA - SIGN INPROPOSALSSAMPLE SUBMISSIONTEST STATUSEXCHANGESIGNINREGISTER
If you have any questions, you may contact your Account Manager. You may also contact us by completing a Contact Us form at https://www.namsa.com/contact-us LOCATIONS & CONTACT INFORMATION Toledo (Global Headquarters) 6750 Wales Road. Northwood, Ohio, USA 43619. Office: +1-866-666-9455 (toll free) Office: +1-419-666-9455 (outside of USA) Get Directions. MEDICAL DEVICE TESTING NAMSA PIONEERED THE MEDICAL DEVICE TESTING INDUSTRY. Established in 1967, NAMSA is the pioneer of the medical device testing industry and continues to serve as the global marketplace leader for reliable, proven testing services. On an annual basis, our teams conduct over 100,000 tests across our state-of-the-art laboratories across theglobe.
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW Background. China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices—or or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.. Over the years, remarkable progress has been made in the evolution and BIOLOGICAL SAFETY TRAINING *** VIRTUAL TRAINING *** Join NAMSA as we launch our NEW virtual Continuing Education for the Biological Safety Specialist Training on June 22-23, 2021 (8:00am-5:00pm Central Standard Time U.S./3:00pm-12:00am Central European Time E.U.).Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. EU COMMISSION UPDATE : NOTIFIED BODIES DESIGNATED TO MDR Update. As of 10 July 2020, there are 15 Notified Bodies designated to MDR and four (4) designated to IVDR, with at least nine (9) additional NBs pending designation. To date, 44 MDR and 11 IVDR applications have been received, recently reported by the EU Commission. The current list of designated Notified Bodies is included below. RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. USP MUSCLE IMPLANTATION STUDY Standards. United States Pharmacopeia. ISO 10993-6. Implantation tests are performed to evaluate the local d pathological effects on living tissue, at both the gross level and microscopic level, after implantation of samples of medical Implantation tests are performed to evaluate the local pathological effects on living tissue, at both the INDUCTIVELY COUPLED PLASMA MASS SPECTROSCOPY (ICP-MS Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Full Scan – is a quantitative analysis that looks for about 46 different inorganic/metallic elements that could extract from the material. These may be related to additives, colorants, etc. used in the device.ABOUT OUR COMPANY
“The results that NAMSA’s expert testing, clinical and consulting teams delivered to our organization were truly exceptional. Not only did NAMSA’s deep-rooted and extensive experience with the U.S. FDA allow us to achieve unparalleled, accelerated results, but their consistency, responsiveness and proactive nature were also key factorsin our success.
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CAREERS | NAMSA
Just a few of NAMSA’s benefits include: A variety of Medical, Dental and Vision programs. 401 (k) program with company match. Annual bonus incentive. Tuition, training and certification reimbursement. Paid holidays and vacation time. Relocation services. Employee assistance programs. Career development and advancement opportunities.OUR HISTORY
developing & delivering novel medical device technologies since 1967. In 1967, a glass manufacturer in Toledo, Ohio approached a clinical laboratory to test polymeric materials for pharmaceutical container testing. While the clinical lab passed on the work, Dr. Theodore Gorski, a scientist-entrepreneur, recognized the opportunity andaccepted
OUR VALUES | NAMSA
OUR VALUES. Since 1967, NAMSA has grown, but the values that defined us from the start are those that still guide us today. NAMSA’s modest roots in medical device laboratory operations in the 1960s and 1970s have evolved to help clients develop and deliver innovativemedical products in
RENEWAL TIMELINES QUICKLY APPROACHING FOR MEDICAL DEVICE The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. NAMSA ELEARNING ISO 10993 SERIES 1 Price. $ 1,625.00. In the 22 parts of this standard, various biological safety endpoints are described and prescribed for evaluation based on a medical device contact type and duration. An evaluation strategy is developed specific to material, device contact, and contact duration; allowing manufacturers to produce devices thatare safe for
ISO INTRACUTANEOUS STUDY ISO 10993-10. Irritation tests are utilized to assess the irritation potential of medical devices, bio-materials, or their extracts exposed to eye, skin, or mucous membranes. The test (s) are performed using a model appropriate for the route (skin, eye, mucosa) and duration of exposure or contact. CYTOTOXICITY STUDY USING THE USP AGAR DIFFUSION METHOD Standards. ISO 10993-5. Cytotoxicity tests are used to determine the lysis (death) of cells, colony formation, inhibition of cell growth, and or other effects on cells caused by medical devices, bio-materials, or their extracts utilizing cell culture techniques. BIOCOMPATIBILITY EXTRACTIONS: THE HOW AND WHY All of this and more are answered in this episode of Biocomp CHAT ibility. “If you are looking at the biocompatibility testing, the concept of extractions is going to come up eventually. Basically, trying to get something that we can dose into a study, whatever study that you are doing. If you are trying to simulate what the human bodymay
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Driven by our global regulatory expertise and in-depth therapeutic knowledge, NAMSA offers only the most proven solutions to move your medical device through the development lifecycle as efficiently and cost-effectively as possible. Offering product development strategy; medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, we are dedicated to helping you achieve accelerated, successful development and commercialization outcomes.Learn More
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Always on the pulse of industry news, we interpret the latest regulatory guidelines and other medical device updates so you don’t have to. Learn what recent news means for your medical device development plans and commercial operations.Access Now
May 25, 2021
MAY 26, 2021: MARKING A REGULATORY MILESTONE FOR EU MEDICAL DEVICEMANUFACTURERS
Today, the EU medical device industry reached a major milestone with the arrival of the extended application deadline for the European Union Medical Device Regulation (EU MDR 2017/745).Read More
May 11, 2021
STAR TRIBUNE INTERVIEW WITH CEO, CHRISTOPHE BERTHOUX: NAMSA IN GROWTH MODE UNDER NEW LEADERSHIP NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in new hands.Read More
May 10, 2021
CHINA STATE COUNCIL RELEASES ORDER 739, CREATING NEW MARKET ACCESS OPPORTUNITIES FOR GLOBAL MEDICAL DEVICE AND IVD MANUFACTURERS China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices (or State Council Order Number 739) on February 9, 2021.Read More
April 28, 2021
FDA QUALIFIES NEW CYBERSECURITY MEDICAL DEVICE DEVELOPMENT TOOL On October 20, 2020, the U.S. Food and Drug Administration’s (FDA) Medical Device Development Tools (MDDT) Program announced the qualification of a new tool for medical device development within cybersecurity risk evaluations.Read More
April 21, 2021
MDCG PUBLISHES NEW GUIDANCE ON USE OF STANDARDS UNDER MDR/IVDR On April 16, 2021, the Medical Device Coordination Group (MDCG) published “Guidance on Standardisation for Medical Devices” (MDCG2021-5).
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