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Quality management for medical devices
ISO 13485
If you are a producer, distributor, or supplier of medical devices, in-vitro diagnostic devices, or active implants, we will certify your quality management system in line with ISO 13485. This standard combines all regulatory requirements relating to medical devices.
Efficient quality and risk management
ISO 13485 is more than just a pure quality management system. In order to meet the high requirements in the field of medical devices, it also integrates a risk management system. This enables you to identify hazards relating to the medical device or the associated procedures at an early stage. You can then take swift, targeted action.
