In the medical device field the name of the game is Compliance. The reason for V&V testing is compliance. Prior to distribution you need to provide evidence of compliance. Everywhere you turn there are rules where the medical device manufacturer or distributor must provide evidence of compliance.

Now this would be an easy task if regulations never changed. Unfortunately, this is not the case. To add to the complexity of keeping up with the latest regulations is the fact that various locations around the world recognize different standards.

These various websites are a sort of cheat sheet that I've utilized in an effort to keep up with the latest regulations pertaining to medical devices:

FDA - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

European Commission - http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm

ASTM - http://www.astm.org/Standard/index.shtml

IHS - http://global.ihs.com/index.cfm?currency_code=USD&customer_id=2125472C330A&oshid=2125472C340A&shopping_cart_id=2125472C340A6&mid=5280&country_code=US&lang_code=ENGL&index_home=true

CSA - http://shop.csa.ca/?k=1&__utma=1.988977504.1361369014.1361369014.1362350391.2&__utmb=1.8.9.1362350434304&__utmc=1&__utmx=-&__utmz=1.1362350391.2.2.utmcsr=shop.csa.ca|utmccn=(referral)|utmcmd=referral|utmcct=/&__utmv=-&__utmk=57114026

IEEE - http://standards.ieee.org/findstds/index.html

BSI - http://shop.bsigroup.com/Navigate-by/Standards/

RTCA - http://www.rtca.org/onlinecart/searchpage.cfm

These websites have helped me stay current as well as educating me on where to acquire the latest standard when necessary.

Hope this helps keep everyone current.

-MJB

 

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