Event / Webinar

Navigating cybersecurity and AI in the brave new world of SaMD

Software development in the Medical Device/IVD industry is challenging, particularly since integrating cybersecurity and artificial intelligence/machine learning. Regulators struggle to keep pace with the advances in software technology and in finding a balance between innovation and compliance, ultimately allowing release of products that are safe to use.

This webinar will unpack some of these challenges to help understand the current regulatory climate, specifically in the area of cybersecurity and AI/ML. We will include an update on how regulators are addressing these topics and provide a practical perspective on how manufacturers can best respond to the challenges.

On-Demand 1 hour Your Desk!

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Speakers

Yervant Chijian

Director, Team Lead, Medical Devices/IVD, PharmaLex
   

 

 

 

Medical Device Software has gained momentum in recent years, specifically the attention from regulators to address the complexities and challenges software bring in this highly regulated industry.

Software development in the Medical Device/IVD industry is challenging, particularly since integrating cybersecurity and artificial intelligence/machine learning. Regulators struggle to keep pace with the advances in software technology and in finding a balance between innovation and compliance, ultimately allowing release of products that are safe to use.

This webinar will unpack some of these challenges to help understand the current regulatory climate, specifically in the area of cybersecurity and AI/ML. We will include an update on how regulators are addressing these topics and provide a practical perspective on how manufacturers can best respond to the challenges.

Key Learnings

  • Current state of updates from major regulators and what these mean for manufacturers. Key considerations for cybersecurity during product development and post-market processes.
  • How to respond to expectations by regulators, documentation and differences based on software platforms.
  • Considerations when incorporating AI/ML in medical device software, including within product development processes, algorithm training, validation, and iterative changes post release.
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