Critical Concepts Medical Device Software: Approaches to Determining Risk Classification, Qualification, and Safety and Performance Outcomes
WebinarIn case you are wondering if Medical Device Software (MDSW/SaMD) and digital health content is a hot topic, the FDA released 4 guidance documents in 2022 alone, on topics ranging from cyber security, medical image devices, and mobile medical applications. Furthermore, the European MDR- EU 2017/745 and new IVDR – EU 2017/746 regulation contain stipulations […]
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