Medical Device Qualified Supplier Directory

 

Amtac Certification Services Ltd. Company Profile

T: +44 161 9288924
F: +44 161 9277359

Address
Norman Rd., Altrincham, Cheshire, WA14 4EP, United Kingdom
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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.

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T: +44 161 9288924
F: +44 161 9277359

Address
Norman Rd., Altrincham, Cheshire, WA14 4EP, United Kingdom
View map