ISO 13485, “Medical devices — Quality management systems — Requirements for regulatory purposes,” 3rd Edition has just been released and it’s available now from Document Center Inc., an authorized ISO distributor. You’ll be able to get a copy in both paper format and as a pdf download. Dated 3/1/2016, this new update replaces the previous 2nd Edition from July 2003.
The medical device industry has been waiting for this update ever since the final draft was approved at the end of last year. This is one of our big sellers for this market sector and will be required in many of our customers’ standards collections. It provides you with requirements for ensuring consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purposes. And it specifically addresses compliance with regulatory and legal requirements.
One thing to note is that the new edition is not only being released as the ISO source document, but also as the European EN edition. So if you’re using the EN ISO 13485, the new 2016 edition of that document is available now as well! And even though EN ISO 13485 2016 Edition is out, it has not made it onto the Harmonized Lists for the various medical device directives yet. It takes a while for newly released EN standards to make it through the administrative process and get posted to the Harmonized Lists. When it does make it, you’ll likely have a three-year transition period for compliance for products sold in Europe.
Contact Document Center Inc. for more information and to learn how to add this standard to our enterprise multi-user subscription platform, Standards Online. We can be reached by phone (650-591-7600) and by email (info@document-center.com).
Or order directly on the www.document-center.com website. Here’s the direct link for the ISO 13485 order page and the direct link for the BS EN ISO 13485 order page. Thanks so much! We appreciate your business.