Services
Regulatory Affairs
If a clinical investigation is to be carried out, essential safety and performance requirements must first be met and essential technical documentation must therefore be created. We have prepared the components in the illustration below.
Our services in the area of “Regulatory Affairs”
We create all the necessary documents and also carry out appropriate regulatory reviews of the documents you have created yourself.
documentation
The aim here should be that all documents represent a correct basis for the study documentation (clinical investigation plan, clinical examiner's manual, etc.) and that the documents required by the authorities and ethics committees are submitted in full.
All documents created here are already part of your technical documentation to meet the basic safety and performance requirements in accordance with Appendix I of the MDR.
We also advise on the necessary verification tests for all products and recommend our partners if necessary. We check and validate your self-created documents so that they meet the legal requirements such as the Medical Device Regulation 745/2017 (MDR) and the requirements of relevant standards and recommendations.
Quality management
At the same time, if necessary, we will also set up your quality management system for you in accordance with MDR and DIN EN ISO 13485.You can find more information here
