ISO 13485:2016
Medical Devices Quality Management System
For organisations that design, manufacture, install or service medical devices.
ClassManagement system standard
Edition2016
What is this standard?
Specifies quality management system requirements for medical devices, targeting the design, production, installation and servicing of medical devices and related services.
Who is it for?
Suppliers of products and services related to medical device design, production, installation and servicing.
What triggers an assessment?
- A medical device or IVD is designed, manufactured or serviced.
- Products or services are supplied to a medical device manufacturer.
- Placing on the EU or another market is intended.
What does it not replace?
- It does not substitute for CE/MDR/IVDR conformity. Device class, target market and economic operator role are mandatory questions.
- It does not substitute for notified body assessment.
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