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Medical Devices
s
Sergiy
on May 15, 2013
Hi DJ, There are no
Hi DJ,
There are no particular plans about Medical Devices standards at this moment.
We actually did some preliminary work a while ago (~1 year), but then all activities were switched to "observation mode". Some reasons are
- Med Dev standard is not finalized. In the past we had quite unpleasant experience working with draft documents.
- We do not see enough interest from Med Dev users and CDRH.
- It also results in a lack of resources for implementation. E.g., expertise in the standard, test/pilot data, users feedback, etc.
Therefore we are just waiting when the industry will be ready and the real demand will exist.
Kind Regards,
Sergiy
Hi all,
I was wondering when/if the 5 new medical devices domains were going to be included for rules implementation soon, since I didn't see any rules for these domains. Thanks!
- DJ