Project reference

Risk management and product approval

Due to new normative, regulatory requirements and product changes, a client needed to revise the risk management files for several legacy products. In addition, a new risk management file had to be created for a clinical prototype.


EXCO was commissioned to support the client by:

  • Obtaining risk management documentation
  • Creation of an as-is analysis including evaluation of the normative and regulatory gaps to be eliminated
  • Creation of a catalog of measures to close the gaps
  • Revising the management plan, risk analysis, risk management report within the customer's risk management team
  • Update of the risk analysis in the customer system
  • Preparation of test reports (TRF-Test Report Form) for the product tests
  • Support product audit preparation

Customer benefit
  • Product audits were passed


Manufacturer of medical devices, Germany

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