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.

2009年 3月 13日

Resource for overview of medical device regs

A lot of people know that the US Department of Commerce publishes short research reports...
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2009年 3月 3日

New EU guidance documents released

In case you missed our newsletter on the topic, Evangeline Loh, our VP of Regulatory Affairs, provided some information on new European clinical data guidance documents released late last year.
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2009年 2月 26日

New European MEDDEV guidance on clinical evaluation

Directive 2007/47/EC which modifies the Medical Devices Directive MDD 93/42/EEC (and AIMDD 90/385/EEC) becomes effective on March 21, 2010. The new Directive includes a definition for clinical data and further enhances the clinical evaluation report expectations of MDD 93/42/EEC, Annex X. To this end, the European Commission recently published two guidelines (MEDDEV documents) related to clinical data.
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2009年 2月 18日

Taking advantage of elabeling for IVD companies

In 2007 the European Commission released MEDDEV 2.14/3 REV 1 which opened the door for IVD companies with professional use products to place their Instructions for Use (IFU) online instead of placing
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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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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 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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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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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 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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