Regulatory & IP Due Diligence Services
Our range of services includes:
Our consultants evaluate with a neutral outside perspective:
- the approval concept and the regulatory maturity level of medical devices,
- the practicability, quality and completeness of the system and process documentation and
- the quality and completeness of the technical documentation of medical devices.
The following procedure has proven to be very effective:
- Visit to get to know the company, its employees, its products and processes,
- Review/analysis of the documents provided,
- Conducting interviews to assess the service providers,
- Checking processes for conformity with requirements,
- Review/analysis of documents/records for evaluation,
- Preparation of the expert opinion/evaluation,
- Presentation of the expert opinion/assessment to the client and
- Support in the further development and optimization of products and processes.