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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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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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MDCG 2022-8: Clarification of IVDR Requirements for Legacy Devices

The MDCG 2022-8 is probably one of the most important IVDR guidance documents that has been published in recent months as it finally clarifies what requirements are/are not applicable to legacy IVDs post-IVDR Date of Application (26 May 2022). This guidance discusses: 1) requirements within Chapter VII for post-market surveillance; 2) market surveillance/vigilance for “legacy devices”; 3) other IVDR requirements for “legacy devices”; and 4) IVDR requirements for devices placed on the market prior to 26 May 2022 (“old devices”).

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MDCG 2022-2: Recommended Strategies for Data Retrieval and Literature Reviews

On January 27, 2022, MDCG 2022-2: “Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)” was published. This document provides information for manufacturers, regulators, investigators, sponsors, Notified Bodies and other industry stakeholders concerning the continuous process for IVD performance evaluation.

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MDCG 2022-6: Transitional Provision Considerations for IVDR Conformity

At the end of May, a new Medical Device Consortium Group (MDCG) document was published by the European Commission: MDCG 2022-6—“Guidance on Significant Changes Regarding the Transitional Provision under Article 110(3) of the IVDR.” This guidance covers important information regarding the implementation of EU Regulation 2017/746, also known as IVDR and discusses key areas such as timelines, as well as the background and purpose of MDCG 2022-6.

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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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