As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

2012年 2月 10日

New FDA Informed Consent Rules Set for March 2012 Implementation

New informed consent requirements for some medical device clinical trials in the US will go into effect March 7, 2012 .
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2012年 2月 8日

FDA Guidance Tackles Off-Label Information Requests in the Digital Age

Guidance published by the FDA in late 2011 intends to update regulatory requirements for medical device manufacturers responding to
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2012年 1月 30日

Nouveaux documents MEDDEVs révisés

Le groupe d’experts européen pour les dispositifs médicaux (MDEG) s’est réuni le mardi 10 janvier...
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2012年 1月 26日

CDRH 2012 Strategic Priorities: Familiar Themes

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published its 2012 Strategic Prioritie s, which include improvements to pre- and post-market processes, internal and external communications, and efforts to support innovative product development.
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2012年 1月 26日

Mexico Expands Equivalency to Devices Registered in Japan

Mexican medical device regulator COFEPRIS has extended its Equivalency Agreement granting expedited reviews for some medical device
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2012年 1月 25日

New Medical Device Regulations Imminent in Russia

Russian authorities are expected to implement new medical device regulations concerning authorized representation, vigilance, country-of-origin approval and other issues within the next several wee
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2012年 1月 23日

US Government to Require Device Manufacturers to Disclose Payments to Doctors

The Obama Administration has announced plans to require medical device and pharmaceutical companies to report payments they make to US doctor and other health care providers for research, consulting and travel.
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2012年 1月 18日

European Med-Tech Trade Groups Join Forces

European medical technology association Eucomed and the European Diagnostic Manufacturers Association (EDMA) are forming a single industry trade federation to more effectively lobby on behalf of their medical device and IVD manufacturing members.
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2012年 1月 13日

Mises à jour réglementaires de l'UE

L’année 2011 touchant à sa fin, nous vous informons de quelques nouvelles de fin d’année en provenance de l'Union européenne.
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2012年 1月 13日

New and Revised MEDDEVs for the European Union

The European Medical Device Expert Group (MDEG) convened on Tuesday January 10, 2012 in Brussels...
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