Presented by
Mirko Klingauf Systems Engineer | Roche Diagnostics
Medical Device Risk Management & ISO 14971 Compliance with Roche
About this talk
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
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Our regular webinars feature PTC Codebeamer's (formerly Intland Software) domain-expert partners, invited professionals from leading digital product development companies, and our own experts. These live sessions (as well as their on-demand recordings) cover a variety of topics related to software-heavy product development in safety- or mission-critical industries. Join our webinars for cutting-edge insights & best practices from industry leaders. Find out how leading innovators are cutting product development time and costs, and how they use Application Lifecycle Management to gain a competitive edge.