10/29/2023 0 Comments En iso 13485 permission numberThe revised standard will be available in the upcoming weeks.ĮN 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). This replaces EN ISO 13485: 2003, although the text of the global standard ISO 13485:2003 is unchanged, only the foreword and annexes in the European version have been revised. The European standard, EN ISO 13485:2012 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes, has been published, after approval by CEN on January 24, 2012.
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