We provide you with a quality assurance system tailored to your activities, train your employees and help you to implement it in practice. In doing so, we accompany your notification to the responsible authorities from the beginning until registration and a possible inspection.
We offer you:
- Support in reporting your activities according to § 67 German Medical Products Act (AMG) - (in terms of § 52c AMG)
- Establishment of a quality assurance system in accordance with § 1a / § 9 AM-HandelsV and Chapter 10 of the EU-GDP Guidelines
- Preparation and follow-up as well as support for a possible inspection by the authorities