Improving Medical Device Risk Management

Traceability is at the heart of quality assurance and is the basis of risk management for medical devices. Read this whitepaper to learn how you can significantly improve the process.

This whitepaper investigates some of the classic challenges of medical device risk management and demonstrates how to improve significantly the process.

It provides a robust repository and workflow management solution that simplifies tasks such as requirements management and reporting, while automating deep traceability.


The whitepaper highlights the following topics:

  • The challenges of medical device risk management
  • A traceability data model
  • A risk management data model
  • Risk management document definition
  • Conclusion


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