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 15日

Nouveaux documents MEDDEV importants pour l'Europe

Le début d’année 2012 apporte des nouvelles importantes dans le monde des documents d'orientation en Europe (MEDDEV). Le groupe européen d’experts pour les dispositifs médicaux (MDEG) a publié quatre MEDDEVs révisés et a ajouté trois documents MEDDEV sur le site Web de la Commission européenne, plus un document d'orientation sur les logiciels autonomes. Ces documents d'orientation représentent des consensus dans l'UE sur une multitude de sujets, même s’ils n’engagent à rien au niveau juridique. Une brève discussion sur les principaux changements ci-dessous va s'ensuivre avec davantage de ressources.
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2012年 3月 14日

Important New European MEDDEV Documents

The start of 2012 brings substantial news in the world of European guidance (MEDDEV) documents and one regulation. The European Medical Device Expert Group (MDEG) has released four revised MEDDEVs while adding three brand new MEDDEV documents to the EU Commission Web site, plus a guidance document on standalone software devices. These guidance documents represent EU consensus positions on a multitude of topics, though are not legally binding. A brief discussion on the major changes follows with further resources below.
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2012年 3月 13日

Final Publication of e-IFU Regulations March 30th

Final publication of the European Commission’s regulations covering electronic instructions for
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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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