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NAMSA

NAMSA is the World’s leading medtech cro offering global end-to-end development services…

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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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Utilization of Least Burdensome Principles during FDA Reviews Benefits Industry

The principles provided in the FDA’s Least Burdensome Provisions Guidance offer useful tools to assess evidence requirements and information on how to effectively navigate the regulatory review process in the United States.

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New MDCG 2022-5 Guidance on Borderline between Devices and Drugs under MDR

In late April 2022, the long-awaited Medical Device Coordination Group (MDCG) guidance on borderline devices under the Medical Device Regulation (MDR) was published. In this newly-released guidance, the MDCG essentially replaces the borderline guidance in MEDDEV 2.1/3 Rev3, originally written for the EU Medical Device Directive (MDD).

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The Repeal of MCIT: 3 Key Takeaways for Medical Device Manufacturers

In November 2021, the Medicare Coverage of Innovative Technology (MCIT) repeal was published in the Federal Register. This decision left start-up MedTech companies wondering if a U.S. Food and Drug Administration (FDA) Breakthrough designation would have advantages over traditional pathways and assist with the medical device reimbursement process.

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FDA Announces Optional Pathway for Clearance of Surgical Sutures

The FDA issued a final guidance on April 11, 2022, establishing the performance criteria for surgical sutures, allowing for clearance of devices through the Safety and Performance Based Pathway.

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FDA Reissues Draft Guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”

On April 7, 2022, the U.S. Food and Drug Administration (FDA) announced the release of draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.”

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