ISO 13485:2016 offers medical device manufacturers a quality management system which translates into greater consistency, improved quality and less risk. The central principle within the standard, as with other recent updated ISO standards, is risk-based thinking throughout the medical device lifecycle.
With the transition period now complete there are a number of lessons learned, including:
- How to maintain an effective ISO 13485:2016 QMS after upgrading
- How to plan and address your internal and external nonconformities
This webinar-on-demand also looks into practical examples for the validation of software used in quality management systems and Quality Agreements with suppliers.
Learn more about the ISO 13485:2016 medical devices standard here.