How ISO 13485:2016 Impacts (medical devices)

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices.

ISO 13485:2016 provides an international standard that can be truly harmonized across multiple regions and regulatory requirements.

To help guide companies through the process, Emergo have produced a useful white paper. With a focus on Quality Management Systems, the white paper looks at:

• 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 re-certfication

For further details, see Emergo.

Posted by Dr. Tim Sandle