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.