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About This Item

 

Full Description

Stay compliant with ISO 13485:2016!

This is a Checklist for ANSI/AAMI/ISO Standard 13485:2016 Medical devices - Quality management systems- Requirements for regulatory purposes ISO 13485. This standard is a requirement for all medical devise producers. This standard goes much further than ISO 9001 in requirements for documentation; and represents a major change in concept, being a "stand-alone" quality system standard for medical devices. The Checklist clarifies what is required for compliance by providing an easy-to-use product evidence list that will assist any organization to meet the requirements of this important standard.

This product comes with 4 hours of free consultation. SEPT will answer any question concerning the standard or Checklist for 60 days after purchase.

New! Order the "Self-Extracting File Format" option to get this product in an editable Microsoft Word document!

 

Document History

  1. Checklist for ISO 13485:2016, Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes

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    Checklist for ISO 13485:2016, Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes

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  2. SEPT ISO 13485 Checklist


    EVIDENCE PRODUCT CHECKLIST for ANSI/AAMI/ISO Standard 13485:2003 Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes

    • Historical Version