EN ISO 13485 2016

9342EEC Annex II

TUV USA ISO 13485 2016 ed 4

TUV USA ISO 13485:2016 under MDSAP


Go to the FDA registration database by following the link. Enter ROVERS in the establishment name field and start search.
Establishment registration

Go to the FDA 510(k) database by following the link. Enter ROVERS in the applicant name field and start the search.
510(k) numbers