ISO-13485
Medical devices — Quality management systems — Requirements for regulatory purposes
Quality management system requirements specific to medical devices. Based on ISO 9001 with additional requirements for design controls, risk management, traceability, and regulatory compliance.
- Document
- ISO 13485:2016
- URL
- https://www.iso.org/standard/59752.html
- Label
- Standard
- Keywords
- quality management medical device QMS design controls traceability regulatory compliance ISO 9001
- Derived from
ISO-9001
Domain: Medical · Standard