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.

2007年 9月 1日

Amendments to the European Medical Device Directives published

The European Commission has officially adopted a new Directive that is of critical importance to most medical device companies selling and/or conducting clinical trials in Europe.
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2007年 10月 12日

Upcoming Changes to the European Medical Device Directive

Recently, we told you about a new Directive (2007/47/EC) that will affect all manufacturers selling medical devices in Europe.
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2008年 2月 27日

Medical Device Clinical Evidence Requirements: Are You Prepared?

Article discusses the changing requirements for clinical evidence for medical devices marketed in Europe.
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2008年 3月 1日

Proposed Changes to the GHTF Regulatory Auditing Guideline

Upcoming changes to QMS auditing requirements have been proposed by Study Group 4 of the Global Harmonization Task Force (GHTF.) These changes may affect your company and you have until 14 MAY 2008
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2008年 3月 28日

New Year, New Details of European Regulatory Changes Ahead

This article first appeared in Medical Products Outsourcing in January 2012. Regarding revisions to the...
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2008年 5月 8日

Are you considered a medical device manufacturer?

It's no secret that today's medical device manufacturers are a diverse lot that exist in...
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2008年 5月 8日

Medical Device Risk Management and Risk Analysis Using ISO 14971:2012

This article discusses ISO 14971:2012 and its application to medical device and IVD manufacturers.
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2008年 5月 12日

Directive 2007-47-EC - Changes to the Medical Devices Directive

If you export to Europe, you will certainly be interested in learning about some important...
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2008年 5月 12日

Medical Device Incident Reporting in Europe

First in a two part article that d iscusses when medical device and IVD manufacturers should report inclidents involving their devices as specified in the Medical Devices Directive (93/42/EEC).
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2008年 8月 26日

EN980:2008 on Medical Device Labeling Released

A very important update to EN 980 has just been released.
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