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.

May 8, 2008

Are you considered a medical device manufacturer?

It's no secret that today's medical device manufacturers are a diverse lot that exist in...
May 8, 2008

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.
Feb 10, 2009

Welcome to QARA.info

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry.
Jan 8, 2009

Italy registration deadline extended; recast of WEEE/RoHS; adverse event reporting possible changes

Medical devices sold in Italy were required to be registered in the Italian Ministry of Health database by December 31, 2008.
Dec 10, 2008

Registration of medical devices in Italy becomes mandatory

Do you sell your medical devices in Italy? Manufacturers have until the end of December 2008 to register their devices as registration becomes mandatory on 1 January 2009.
Nov 25, 2008

BS EN 1041:2008 Revision to the Medical Devices Directive

A new revision to BS EN 1041:2008 has been released. This Standard specifies the information that must be supplied with each medical device sold in Europe.
Aug 26, 2008

European borderline classification issues

Another version (1.1, May 2008) of the Manual on Borderline and Classification in the EU Community has been published.
Aug 26, 2008

EN980:2008 on Medical Device Labeling Released

A very important update to EN 980 has just been released.
May 12, 2008

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).
May 12, 2008

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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