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 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
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.
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.
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...
2009年 3月 13日

New requirements - electrical medical devices sold into Ontario Canada

Effective April 1, 2009 manufacturers of electrical medical devices and manufacturers of electrical components that...
2009年 3月 19日

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
2009年 4月 9日

US FDA issues notice on preamendment Class III medical devices

The FDA has posted an order in the Federal Register (Thursday, April 9, 2009, Vol. 74, No.
2009年 4月 9日

US FDA issues notice on preamendment Class III devices

The Food and Drug Administration (FDA) just posted a notice in the April 9, 2009 Federal Register notifying manufacturers of 25 types of Class III medical devices that their products will be subject t
2009年 5月 1日

US FDA announces new website

The Food and Drug Administration has said that it plans to launch a redesigned website, presumably in 2009. This should be good news for users of the site. Hopefully, guidance documents and other relevant information will be easier to find, and databases will be easier to use. Keep your fingers crossed.
2009年 5月 8日

US FDA may get large increase in funding

Today the Wall Street Journal published an article noting that President Obama has requested an additional $300,000,000 in funding for the US FDA, from $2.06 billion to $2.35 billion. That's a 14% increase. If the funding is approved by Congress, the agency will likely hire more inspectors which will lead to more frequent visits from the FDA to medical device manufacturers.