ISO 13485:2016
Medical Devices Quality Management System
ISO 13485 (2016) is a management system standard: Medical Devices Quality Management System. Specifies quality management system requirements for medical devices, targeting the design, production, installation and servicing of medical devices and related services. It applies to suppliers of products and services related to medical device design, production, installation and servicing.
- Class
- Management system standard
- Edition
- 2016
- Related sectors
- 2
- Last verified
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.
What ISO 13485 does 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.
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.
Official source
Last verified:
This page is for information only; it is not legal advice. A record appearing here does not mean it is required for your business. This library does not issue certificates.