[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

Sign up for future webinars here.

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


About the Blog

In this blog, we share our insights and experiences to help companies build quality, scalability, and flexibility into their regulatory writing.  We hope you find it insightful. For questions, please contact info@criterionedge.com.

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