Technical Documentation

Conformity Assessment. CE Mark.

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