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.
Who should register for this webinar?
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve clinical evaluation reports for MDR submissions.