The new ISO 13485 revision is here and, for medical device manufacturers, this is significant news.
ISO 13485:2016 provides an international standard that can be truly harmonized across multiple regions and regulatory requirements. But it also introduces notable QMS changes, particularly in the area of risk management. In this 16-page white paper, we answer your biggest questions about ISO 13485:2016, including:
- Overview of the update to the new standard
- Breakdown of what has changed in each section
- Guidelines on how to prepare for the new standard
- Deadline for recertification
- Requirements for recertification
- Considerations for timing the update and recertfication
With this, Emergo has issued a white paper, which introduces the standard. It can be accessed here.
Posted by Dr. Tim Sandle