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Software as a Medical Device (SaMD): EU/US Regulatory Considerations

Software as a medical device (SaMD) is becoming more and more common in the medical device landscape and will certainly have an impact on the regulatory landscape.

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Watch now: Software as a medical device (SaMD): EU/US regulatory considerations

While traditional medical devices contain some hardware components, devices considered software as a medical device (SaMD) are becoming more common in the medical device landscape.

Webinar date

Oct. 27, 2022

Speaker

Sarah Fitzgerald, U.S. regulatory program manager and a senior consultant, Quality and Regulatory Affairs, Emergo by UL

 

This webinar will help you gain a better understanding of considerations for designing and classifying SaMDs in the United States and European Union, as well as outline recent and expected changes.

Learning objectives:

  • Classification of SaMDs.
  • Design of SaMDs.
  • Artificial intelligence (AI)/machine learning (ML) considerations.
About the presenter:

Sarah Fitzgerald, U.S. regulatory program manager and a senior consultant, Quality and Regulatory Affairs, Emergo by UL

Sarah Fitzgerald has more than 15 years of experience in medical device regulatory and quality affairs, including supporting products from concept to end-of-life. Fitzgerald has extensive experience with regulatory strategy for the U.S. and EU and has compiled many U.S. submissions, including 510(k)s, emergency use authorizations (EUA)s, and Q-submissions. She has worked with a wide variety of devices, including software as a medical device (SaMD) and medical devices with software. She is the U.S. regulatory program manager and a senior consultant, Quality and Regulatory Affairs, at Emergo by UL.

 

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