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These annexes link the clauses in ISO 13485:2003 with the requirements of the conformity assessment annexes of Directives 90/395/EEC, 93/42/EEC and 98/79/EC respectively. The section that has been changed is the Foreword and in particular Annex ZA, Annex ZB and Annex ZC.
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Thefore the ISO 13485 audit criteria being assessed by a certification body or Notified Body have not changed. The scope, terminology and the requirements contained in sections 4 to 8 of EN ISO 13485:2012 are exactly the same as those in ISO 13485:2003. However as it contains no new requirements manufacturers that have been successfully audited by a Notified Body will not normally require any changes to their quality management system. This standard will soon be the harmonized standard for quality management systems under EC Directives 90/385/EEC (Active Implantable Medical devices), 93/42/EEC ( Medical Devices) and 98/79/EC (In Vitro Diagnostic Medical Devices).
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List of registrars recognized by Health Canada (HC) under section 32.1 of the Medical Devices Regulations (MDR).Transition to the revised version of ISO 13485 and it's impact on the compliance to the Quality Sytem requirements of the Canadian Medical Devices Regulations.Cessation of Recognition of Orion Registrar inc.
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The Training Modules are available in Microsoft PowerPoint and Portable Document Format as an alternate format to the Study Guide. The following Training Modules summarize the contents of the Study Guide GD211: Guidance on the content of quality management system audit reports and are available as a convenience to the user. Study Guide GD211: Guidance on the content of quality management system audit reports.Form F202 Submission of a New or Modified Quality Management System Certificate.