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:
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.