What is ISO 13485?
ISO 13485 (Quality Management System – Medical Devices)
- ISO 13485:2016 is an international Quality Management System (QMS) standard for medical devices and related services.
- Covers design, production, installation, and servicing of medical devices.
- Requires organizations to implement and maintain an effective quality system.
- Revised in 2016 to align with technological advancements and regulatory updates in the medical industry.
- Puts greater emphasis on risk management within the medical device supply chain.
- Globus Certifications provides ISO 13485 certification for medical device systems.
