ISO 13485:2016
Medical devices — Quality management systems
International standard for quality management systems specific to medical devices
- Category
- Harmonised standards
- Market
- European Union
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device, Class A IVD, Class B IVD, Class C IVD, Class D IVD
In practice
The basis of the manufacturer’s quality system. Certification is frequently expected by notified bodies. Covers management, design, purchasing, production and control.
Official sources
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