Medical Devices
Medical devices and durable medical equipments
- Reporting, assistance with licensing, and coordination on request
- Translation, adaptation, verification of label text and user information
- Preparation of clinical documentation:
- literature background (State of the Art)
- clinical evaluation plan
- clinical evaluation
- writing a clinical protocol
- clinical trials
- Categorization
- Verification of technical documentation
- Assisting in compliance to MDR (EU 2017/745)
- Providing responsible person
- Development of medical devices
