Experts Talk: Medical Device Risk Management & ISO 14971 Compliance with Roche | Webinar recording

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