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Month: May 2018

EU MDR and IVDR Compliance Planning Resources

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The European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, set forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU. Increased regulatory oversight, expanded clinical evidence requirements, greater requirements for IVD manufacturers and … Continued

NAMSA Recognized as Leading Medical Device CRO for Second Consecutive Year by Life Science Leader

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TOLEDO, Ohio – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical research and regulatory consulting services, announced today that it has been recognized for excellence in clinical research and honored for the second consecutive year as a 2018 “CRO Leadership Award” winner. The CRO … Continued