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.

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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2008年 8月 26日

European borderline classification issues

Another version (1.1, May 2008) of the Manual on Borderline and Classification in the EU Community has been published.
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2008年 11月 25日

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.
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2008年 12月 10日

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.
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2009年 1月 8日

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.
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2009年 2月 10日

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.
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2009年 2月 11日

Significant number of people using mobile phones to access web

We recently did a study of our medical device and IVD clients and asked them how they use their mobile phones.
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