The publication of ISO 13485:2016 introduced significant changes for device manufacturers around the world. Some changes are specific, while others relate to the overall approach to quality management systems for device companies. After watching this video, you will have a better understanding of the most significant changes in the new standard, including how the changes will affect:
- executive management
- data, design, and other controls
- your suppliers
- your employees
You'll also learn when you need to recertify to the new standard and how to plan your transition.