Medical Devices

Pinnacle 21 Support SDTM
1

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

2

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