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 3月 8日

Mobile Health Sector to Reach $23 Billion by 2017

PricewaterhouseCoopers and mobile operator industry association GSMA expect global mobile health revenues to hit $23 billion by 2017, with the biggest markets in Europe and the Asia-Pacific region. A new report recently issued by the two entities, Touching lives through mobile health: Assessment of the global market opportunity , projects that European and Asia-Pacific markets will each make up 30% of global mobile health market share, followed by North America (28%), Latin America (7%) and Africa (5%).
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2012年 3月 2日

CDRH Head: End Substantial Equivalence for Some 510(k) Applications

Center for Devices and Radiological Health (CDRH) director Jeffery Shuren has advocated rejection of 510(k) clearances in instances where applicants’ predicate devices have undergone safety recalls .
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2012年 2月 22日

FDA Explains Electronic Study Data Submission Expectations

New guidance from the US Food and Drug Administration spells out how medical device manufacturers and study sponsors should format
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2012年 2月 13日

Tighter EU Regulatory Controls Proposed following PIP Controversy

European Union member states should take immediate steps to
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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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