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Risk management is a key life cycle process for medical devices. A challenge is the information flow and consistent documentation of interfaces with the clinical evaluation and usability engineering.
That is important for the initial market approval and updates required during the post-market surveillance phase.
In this on-demand webinar we will explain the interfaces and demonstrate, how you can link information between these processes in Polarion in order to demonstrate compliance with regulatory requirements.
We will cover the following topics:
- Information from the risk analysis that is used as input for the clinical evaluation and vice versa
- Achieve consistency of the benefit/risk assessment in the clinical evaluation report and risk management report
- Data transfer between usability engineering file and risk analysis
- Ensure that relevant use scenarios are validated with the summative user interface evaluation
- Visualize the traceability between use errors from the usability file, risk analysis and design input requirements/specifications