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, he will talk about the implementation of ISO 14971:2019 – Application of Risk Management for Medical Devices in codeBeamer ALM.
During the webinar, we’ll touch on the following topics as well as receiving audience questions:
-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