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.
Watch this webinar to find out more about the topic of software as a medical device!
Who is this webinar for?
Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review, or approval of Clinical Evaluation Reports for MDR submissions.
|March 15, 2023||Watch at a Convenient Time||Recorded|
Takeaways from this session:
How to recognize if your software is considered a medical device
How to address the clinical evaluation for your medical device software
How to define the safety and performance outcomes, and other clinical evaluation parameters