The third edition of ISO 13485 is now available. With extensive changes to the scope of the standard, understanding the full extent of the impact on your organization can be a challenge. BSI has released expert commentary on the changes in the new standard which gives you a great understanding of the updated version.

Preview the Expert Commentary here

Fill the form below to download the full ISO 13485:2016 Expert Commentary:

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The free commentary includes:

  • Information on the European foreword and Annexes that show when the regulatory requirements are covered, partly covered or not covered
  •  Provides a context for the new structure of clauses and subclauses 
  • Explores the expanded scope of the standard which is now applicable to many more companies in the medical devices supply chain.