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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 is a medical CRO offering only the most proven solutions to move your medical device through the development lifecycle as efficiently and cost-effectively as possible.

As a medical contract research organization, we are dedicated to helping you achieve accelerated, successful development and commercialization outcomes. NAMSA’s offerings include medical device testing; regulatory, reimbursement and quality consulting; and clinical research services.

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Resources

Learn from the world’s leading medical CRO with 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 from the world’s most trusted medical device CRO to stay up-to-date on recent news and what it means for your medical device development plans and commercial operations.

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EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI)

In an important step forward for EU manufacturers of devices without a medical purpose, the final version of the ‘Implementing Regulation’ containing the common specifications related to the Medical Device Regulation (MDR) have been adopted.

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Auditing a QMS According to ISO 13485

Medical device manufacturers must first ensure that their QMS conforms to the specified requirements and is effectively implemented and maintained. On the path towards ISO 13485 certification, manufacturers should undergo an internal audit and then an external certification audit. This article supports manufacturers in understanding the auditing process toward ISO 13485 certification.

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NAMSA Transforms Integrated MedTech Commercialization Solution: The NAMSA APEX Program

NAMSA announced today the transformation of its integrated MedTech commercialization solution: the NAMSA APEX Program. NAMSA’s strategic outsourcing solution is introduced at a time when the MedTech industry is experiencing changing regulatory requirements and expanding clinical evidence demands

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NAMSA ACQUIRES UK-BASED PERFECTUS BIOMED GROUP TO ENHANCE CUSTOMIZED MICROBIOLOGICAL SOLUTIONS

NAMSA, a world-leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today its acquisition of Perfectus Biomed Group, a UK-based laboratory providing customized microbiological services.

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FDA Releases Long-Awaited Final Guidance for Clinical Decision Support Software

On the heels of the September 26 release of the FDA's, “Digital Health Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings,” the regulatory authority has released the long-awaited final guidance for “Clinical Decision Support Software” (September 28, 2022). This final guidance replaces the 2017 and 2019 draft guidance documents.

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