The third edition of ISO 13485 has now been published. 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.
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.
Other changes examined in the expert commentary include:
- The incorporation of risk-based approaches to safety and performance and regulatory requirements beyond product realization
- Harmonization of software validation for applications for QMS, process control, and monitoring and measurement
- The new emphasis on complaints, reporting to regulatory authorities, and post-market surveillance.
The Expert Commentary on ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes has been developed and reviewed by leading industry experts.