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Consultant Richard Koch on combining IEC 62304 with Agile on Jira

Consultant Richard Koch on combining IEC 62304 with Agile on Jira

Richard Koch has a rare expertise: he guides teams in transforming clinical data into medical products and develops his own medical device software. Based in Switzerland, Richard is at the heart of one of the largest MedTech hubs. His methods are fresh and at the innovation forefront. He aims to combine regulatory standards with Agile principles. IEC 62304 is the main reference for his work as it specifies the processes governing the development of software in medical devices. Many of his customers are companies in the SaMD (Software as a Medical Device) area. These are software developers making Apps that fall under the legal definition of...

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