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Partnering with Existing Owners and Management, ArchiMed Acquires Majority Interest in NAMSA, the World Leader in Medical Device Testing

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NAMSA is the World’s Only 100% Medical Device-Focused CRO offering global end-to-end development solutions…

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DRIVEN BY ITS GLOBAL REGULATORY EXPERTISE AND IN-DEPTH THERAPEUTIC KNOWLEDGE…

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FROM CONCEPT TO POST-MARKET, DELIVERING SIGNIFICANT TIME SAVINGS COMPARED TO INDUSTRY AVERAGES…

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HELPING medical device SPONSORS IMPROVE HEALTHCARE SINCE 1967.

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Our Services

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.

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Resources

Gain complimentary access to our latest white papers, webinars and other resources to learn proven strategies and best practices for successful medical device development and commercialization outcomes.

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Blog

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.

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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.

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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.

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Partnering with Existing Owners and Management, ArchiMed Acquires Majority Interest in NAMSA, the World Leader in Medical Device Testing

Private equity healthcare specialist ArchiMed has acquired from the founding Gorski Family a majority stake in NAMSA, the only full continuum Contract Research Organization (CRO) in the world focused exclusively on medical devices. NAMSA’s President and CEO, John Gorski, the Gorski Family and senior managers will hold stake in the company amounting to a significant double-digit percentage. The price of the transaction is undisclosed.

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Key Considerations for Executing Clinical Trials for Dual 510(k) and CLIA Waiver Applications

With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.

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EU Commission Update : Notified Bodies Designated to MDR/IVDR

With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.

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