Amtac Certification Services Ltd.

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.