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NAMSA

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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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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The IVDR Compliance Roadmap: From Start to Finish

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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IVD Clinical Trials in the Era of COVID-19: Time to go Virtual?

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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PharmTech Outlook: Cover Story Featuring NAMSA President & CEO, John Gorski

Over the last decade, the pharmaceutical and medical device industries have undergone significant transformative trends and innovations. These shifts have rapidly improved efficiency and lowered costs while bringing an increased focus to personalized patient care. According to a 2019 study by Research and Markets, sales in the pharmaceutical industry are expected to rise to $900 billion in 2019 to $1.2 trillion by 2024, while the global medical device market is expected to grow at a CAGR of 5.33 percent to $521.64 billion by 2022.

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European Commission Mandate for EU Parliament Negotiations on MDR Delay: Clarification Regarding Article 120(3)

On 3 April 2020, NAMSA’s EU Regulatory experts provided a critique of The European Commission’s proposal to delay the date of MDR application. Since this time, the European Council provided feedback regarding the European Commission’s proposal to delay the date of application of certain provisions of Regulation (EU) 2017/745 on Medical Devices (MDR) by one year to 26 May 2021 in light of the COVID-19 Pandemic.

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