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Critical Concepts Medical Device Software: Approaches to Determining Risk Classification, Qualification, and Safety and Performance Outcomes
In 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 related to how software is regulated, classified, and qualified.
You may be asking yourselves:
– Is my software considered a medical device?
– How do I address the clinical evaluation for my medical device software?
– How do I define the safety and performance outcomes, and other clinical evaluation parameters?
Join us for answers to these questions and to find out more about the topic of software as a medical device!
Watch the recording of this webinar here.