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Cертификат ISO 13485:2012

EN ISO 13485 provides a framework to enable a manufacturer to meet some of the quality system requirements for an EC Declaration of Conformity (Annex 2 and Annex 5 of Directive 90/385/EEC AIMD; Annex II, V and VI of Directive 93/42/EEC MDD; or Annex III, IV and VII of Directive 98/79/EC IVDD). As the EU harmonized standard for medical device quality management systems, it is an essential tool allowing medical device manufacturers to prove evidence of compliance to the European legislation, based on a sound regulatory interpretation for implementation in their quality management systems.

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