ISO 13485 — Medical Devices Quality Management
ISO 13485 sets requirements for a quality management system specific to organisations involved in the design, production, installation and servicing of medical devices.
Why it matters
Regulators worldwide reference ISO 13485 as the benchmark quality system for medical device manufacturers, aligning with regulatory requirements such as the EU MDR and FDA QSR.
Certification demonstrates risk-based process control, traceability and regulatory compliance across the device lifecycle.
Supporting the UN Sustainable Development Goals
Regulatory alignment
Supports EU MDR, FDA QSR and other global medical device regulatory frameworks.
Patient safety
Risk-based design and production controls reduce harm to end users.
Full traceability
Device history records support rapid, accurate recall action if ever needed.
Market access
A near-universal requirement for medical device market entry.
Organisations that benefit
