Roche is adapting codeBeamer ALM for its Application Lifecycle Management processes including requirements, test, risk, and defect management. Mirko Klingauf, a Systems Engineer at Roche Diagnostics in Switzerland, is tasked with the implementation.
In this webinar, Mirko talks about the implementation of ISO 14971:2019 – Application of Risk Management for Medical Devices in codeBeamer ALM at Roche.
The webinar touches on the following topics:
- Using codeBeamer ALM to manage requirements, tests, risks, and defects
- Decomposing risk elements into codeBeamer trackers
- Mapping the risk status model to the risk assessment process
- Configuration and release management of risks