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Month: February 2018

NAMSA Introduces French Website to Provide Resource for Accelerated Medical Device Development in Europe

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28 FEBRUARY 2018 – LYON, FRANCE – (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, is pleased to introduce its newly launched French language website. The release of this online resource comes as a result of significant, increased demand … Continued

CFDA Releases Technical Guidelines for the Acceptance of Overseas Clinical Trial Data of Medical Devices

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On January 11, 2018, the China Food and Drug Administration (CFDA) issued “Technical Guidelines for the Acceptance of Overseas Clinical Trial Data of Medical Devices.” These guidelines pertain to the acceptance of overseas clinical trial and evaluation data that are submitted by medical device and In Vitro Diagnostics (IVD) registration applicants in China. It is … Continued

EU Commission Issues “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products”

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On 10 January 2018, the EU Commission issued the document, “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products.” While this notice does not contain information previously unknown to the UK government and medical device sectors, it does emphasize the implications of the failure of the UK … Continued

NAMSA Expands Medical Device Testing Services in Germany to Increase Access to Accelerated Product Development

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The world’s only Medical Research Organization brings 50 years of testing leadership to Germany with new Analytical Services Laboratory. FRANKFURT, GERMANY – February 1, 2018 – NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated testing, clinical research and regulatory consulting services, is pleased to announce the launch of … Continued