Medical Device Risk Management and ISO 14971 Compliance with Roche

Presented by

Mirko Klingauf Systems Engineer | Roche Diagnostics

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 Intland's domain-expert partners, invited professionals from leading digital product development companies, and Intland's 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.