For CE marking of a medical device the Medical Device Regulation 2017/745 requires that a technical file (or: technical documentation, design dossier) is created and maintained for the device. Knowledge of the required content of the technical documentation is essential for the development of products or in the acquisition of (partially) completed product development.
Our services include:
- Review of existing documents
- Compilation of technical documentation
- Evidence of compliance with the "Essential Requirements"
- Implementation and documentation of risk management
- Clinical evaluation
- Revision or creation of missing documents
The Capamed Advantage:
- We review your project from the beginning and provide you a comprehensive list of documents and findings necessary for technical documentation
- No delays in obtaining approvals and launching your product
- No serious deviations for inspections by the FDA, competent authority or Notified Body