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.

Mar 19, 2009

Updated list of recognized Standards published by US FDA

The Center for Devices and Radiological Health (CDRH) within the US Food and Drug Administration has published an updated list of recognized standards used in premarket reviews of medical device submi
Mar 13, 2009

New requirements - electrical medical devices sold into Ontario Canada

Effective April 1, 2009 manufacturers of electrical medical devices and manufacturers of electrical components that...
Mar 13, 2009

Resource for overview of medical device regs

A lot of people know that the US Department of Commerce publishes short research reports...
Mar 3, 2009

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.
Feb 26, 2009

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.
Feb 18, 2009

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
Feb 11, 2009

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.
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.

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