ISO 13485: Medical Devices — Quality Management Systems
January 1, 20261 min read
Regulatory Guidance
This content is provided for educational purposes. Always consult official regulatory sources and qualified professionals for compliance decisions.
The global standard for Medical Device Quality Management Systems (QMS), required for regulatory purposes in most major markets.
Overview
This standard identifies the requirements for compliance within the global healthcare ecosystem. Adherence ensures patient safety and regulatory alignment.