[FREE WEBINAR] Critical Concepts Webinar Medical Device Software: Approaches to Determining Risk Classification, Qualification, and Safety and Performance Outcomes


Click here to watch the recording of this webinar.

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? 

Click the link above to get answers to these questions and to find out more about the topic of software as a medical device.

Who are the Panelists?

Laurie Mitchell, President of Criterion Edge, and Stacie Beecham

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Criterion Edge has the expertise and resources to write your clinical or performance evaluation report. Ready for a free consult?


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[Free Webinar] IVDR Readiness: Creating a Blueprint to Build a Strong PER

Join us on Wednesday, June 7th, 2023 at 11 AM PST, as our regulatory experts discuss the process of writing a PER, with careful attention to the importance of aligning technical documents to create a cohesive, well-organized report.

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