Medical Devices Quality Management
Specialized quality management standard for organizations involved in the design, production, installation and servicing of medical devices.
ISO 13485 is the international standard for quality management systems in the medical device industry. It is based on ISO 9001 but includes additional requirements specific to medical devices and regulatory compliance.
The standard ensures that medical device manufacturers consistently meet both customer and regulatory requirements, with emphasis on risk management, design controls, and post-market surveillance.
This page summarises ISO 13485:2016 (current published edition). Always confirm the detail against the published document.