Medical Device Qualified Supplier Directory
Amtac Certification Services Ltd. Company Profile
T: +44 161 9288924
F: +44 161 9277359
Norman Rd., Altrincham, Cheshire, WA14 4EP, United Kingdom
Qualifications: ISO 9001, ISO 13485
Markets Supplied: North America, Europe
Covers CE marking for all medical devices under Annexes II, V, and VI of 93/42/EEC, as well as for private-labeled IVD devices. Activities include provision of quality certification services for ISO 900 and ISO 13485 and participants in the Canadian (CMDCAS) regulations and EU/FDA mutual recognition agreement. Services also include assessor and lead assessor training, product testing, and CE marking approval.