For CE marking of a medical device the Medical Device Directive requires that technical documentation is created and maintained. The technical documentation is required for all classes of medical devices. The content is defined in the Medical Device Directive (Annex 2 and Annex 7).
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 FDA, competent authority or Notified Body