ISO 13485:2016 — Medical devices — Quality management systems — Requirements for regulatory purposes
Summary
The foundational quality management system standard for the medical device industry. ISO 13485 specifies requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It is harmonized under both the EU MDR and IVDR and recognized by the FDA, Health Canada, and regulatory authorities worldwide. Certification to this standard is often a prerequisite for market access in most jurisdictions.
Standard Details
- Standard Number: ISO 13485:2016
- Type: ISO Standard
- Published by: ISO
- Official Link: https://www.iso.org/standard/59752.html
This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.