Certification body/notified body
The certification agency comprises of the following areas:
- Certification of quality management systems – testing of quality management systems according to DIN EN ISO 13485
- certification of quality assurance systems according to annex II, V and VI of directive 93/42/EEC ("MDD") - only in combination with certification of a quality management system
- Product certification – certification of medical devices according to attachment IV of directive 93/42/EEC
You will find a list of proofs and accreditations under accreditation / certification.