ISO 13485:2016 — Medical Devices Quality Management
ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and applicable regulatory requirements.
Who Needs ISO 13485?
Organisations involved in design, development, production, storage, distribution, installation, or servicing of medical devices — including suppliers providing products or services to such organisations.
Key Benefits
- Demonstrates compliance with global medical device regulations
- Improves product safety and quality in the medical device supply chain
- Required by many healthcare buyers and regulatory authorities
- Reduces product recalls and quality-related incidents
- Builds confidence with healthcare organisations and regulators
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