ISO 13485:2016 specifies quality management system requirements for organisations involved in the life cycle of medical devices. It emphasises risk management, traceability and regulatory compliance.
Who it is for
- Medical device and component manufacturers
- Suppliers and contract manufacturers to device companies
- Distributors and servicing organisations for medical devices
Benefits
- Supports CDSCO and international regulatory submissions
- Strong design control, traceability and risk management
- Required by many global device buyers
How we help
Our consultants run a gap assessment, help you build the documentation and processes, train your team, conduct an internal audit, and support you through the certification audit with an accredited certification body.
Frequently asked questions
Is ISO 13485 the same as ISO 9001?
It is based on ISO 9001 but adds medical-device-specific requirements such as risk management, sterile product controls and regulatory documentation.