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

 

We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!