For CE marking of a medical device the Medical Device Regulation requires that technical documentation is created and maintained. The technical documentation is required for all classes of medical devices.
Our services include:
- Review of existing documents
- Compilation of the technical documentation
- Evidence of compliance with the "Essential Requirements"
- Implementation and documentation of risk management (ISO 14971)
- Compliance with applicable standards
- Clinical evaluation
- Revision or creation of missing documents
The Capamed Advantage:
- We review your documentation or project plan and provide you a comprehensive list of documents which are required for the technical documentation
- We author or improve required documents
- No delays in obtaining approvals and launching your product
- No serious deviations for inspections by the competent authority or Notified Body