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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. 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 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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* Go to Client Portal NAMSA IS THE WORLD’S ONLY 100% MEDICAL DEVICE-FOCUSED CRO OFFERING GLOBAL END-TO-END DEVELOPMENT SOLUTIONS… Hear from our clients DRIVEN BY ITS GLOBAL REGULATORY EXPERTISE AND IN-DEPTH THERAPEUTICKNOWLEDGE…
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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
November 09, 2020
CDRH COVID-19-RELATED WORKLOAD IMPACTS Q-SUBMISSION REVIEWS In recent weeks, NAMSA has become aware of instances in which the U.S. Food and Drug Administration (FDA) CDRH Office has closed Q-Submissions without review, citing resource constraints stemming from the COVID-19 Pandemic. With the FDA’s commitment to protecting public health, the agency has allocated resources to focus on COVID-19-related activities, working alongside other federal, state and local agencies and officials to address the pandemic.Read More
October 22, 2020
INDUSTRY UPDATE: ACCREDITATION SCHEME FOR CONFORMITY ASSESSMENT As discussed in NAMSA’s December 19 blog post, “The Evolution of the Accreditation Scheme for Conformity Assessment,” ASCA is an assessment created by the U.S. Food and Drug Administration (FDA) following amendments to Section 514 by the FDA Reauthorization 95 Act of 2017 (FDARA). The assessment was initiated as part of the enactment of the Medical Device User Fee 96 Amendments of 2017 (MDUFA IV).Read More
October 19, 2020
FDA RELEASES NEW DRAFT GUIDANCE FOR BIOCOMPATIBILITY OF DEVICES IN CONTACT WITH INTACT SKINRead More
September 23, 2020
UPDATE: PMDA REVIEW TIMELINES FOR MEDICAL DEVICE AND IVD PRODUCTS The Pharmaceutical and Medical Devices Agency (PMDA) is an independent administrative institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. One of the major functions of this agency is to review marketing applications of medical devices and in vitro diagnostic (IVD) products. In recent years, the PMDA has provided sponsors an annual report on review performance to assist in understanding the predictability and associated timelines for regulatory approval.Read More
September 09, 2020
UKCA: A WAIT AND WATCH APPROACH? On 1 September 2020, the gov.uk website published a new guidance document for manufacturers that place medical devices on the British market. Specifically, this document provides guidance on securing the UK Conformity Assessed (UKCA) mark from January 2021 onward.Read More
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