Medical Device Risk Management & ISO 14971 Compliance with Roche - ERP Spain.com - España y América Latina

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