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Strategic Cybersecurity for Regulatory Success—Are You Aligned?

 

12 and 14 November 2025  •  9:00 AM – 5:00 PM ET  •  12.0 RAC Credits

 

Health authorities spanning the US, European Union, Australia, Canada, and Japan have issued cybersecurity guidance that is essential for regulatory affairs professionals to understand. In addition to premarket concerns, some of the guidance also includes expectations for postmarket.

Cybersecurity Unauthorized, our interactive virtual workshop taking place on 12 and 14 November, will help regulatory and quality assurance professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations.

After this workshop, you will be able to: 

  • Thoroughly understand international regulatory expectations for medical device cybersecurity
  • Know the main components of a product security program aligned with global expectations
  • Understand how to use pre-submissions to reduce the likelihood of cybersecurity-related deficiencies
  • Be able to build more successful cybersecurity content for regulatory submissions
  • Know key medical device security standards

 

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Ben Kemp