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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.
Implementation
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
Client
Manufacturer of medical devices, Germany