![]() I'd say that the main decision for you is likely not EN versus ISO, but rather 2003 version versus 2016 version. ![]() For example, if you intend to market in Canada, they'll tack on CMDCAS requirements (to meet Canadian medical device regulations requirements). When you start to shop around for a Certification Body (CB), they will ask you about your devices and where your intended markets are, and tack-on any "extras" accordingly. (2) might be cheaper, but as was pointed out in this thread, you can also get a single-license copy of the EN version from Estonian Standards for only 20 Euros! Purchase the ISO 13485 version, and supplement with the free preview of the Z-annexes from the webstores (see link in previous post).Įither will give you the same content. Purchase the EN ISO 13485 version (with Z-annexes included) orĢ. ![]() Click to expand.The answer is: it doesn't matter for this standard. ![]()
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