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 our Medical Device Single Audit Program.
Or, contact us to see how SAI Global has helped organizations like yours.