Medical Devices

Services for manufacturers of medical products

Certification of medical products with the CE mark

- Active and inactive medical devices
- Active implantable medical devices
- In-vitro diagnostic medical devices

EMC (electromagnetic compatibility)
CB scheme – approvals acknowledged all over the world
International approvals for medical devices
Certification of conformity with EN ISO 13485 (and EN ISO 9001)
Certification of quality management systems for handling medical products depending on the risk category considering critical products
GM Mark (proper medical product) – distinction for your product in the market
Microbilogical tests of medical products
Certification of declaration form verification
Voluntary mark of conformity
Medical aids
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