Medical Device Risk Management and ISO 14971 Compliance with Roche

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

Our webinar is intended for:

Systems Engineers, QA Professionals, Heads of Testing & QA, Product Owners, Project Managers and Team Leaders, Internal Auditors, Business Analysts