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Twelve-step transition process from
ISO 13485:2003 to the 2016 revision

Download a complimentary white paper (PDF)

This white paper explains how to transition from ISO 13485:2003 to the 2016 revision. Intended for companies that have already implemented ISO 13485:2003, you will learn the twelve steps for a successful transition to the latest 2016 revision of the standard, including:

  • Identification of regulatory requirements and documentation of organizational roles
  • Control of processes and related changes
  • Documentation requirements
  • Identification of medical products

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