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The FDA ‘Cybersecurity Refuse to Accept Policy’ (RTA) will affect Medical Device Manufacturers!

On March 29, 2023 the FDA issued an updated final guidance on the Refuse to Accept (RTA) policy relating to acceptance of premarket submissions. A significant change is the inclusion of cybersecurity-related documentation for medical devices with external wired and/or wireless communication interfaces, including “Cyber Devices” as defined in the newly-amended FD&C Act (Section 524B). In mapping its guidance to its new statutory authority, the FDA specifies what is expected when a submission is provided to the agency for review.What does this mean for medical device manufacturers? Join the free webinar to hear from MedCrypt’s FDA expert Naomi Schwartz

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September 14, 2023

10:00AM PT/1:00PM ET

Limit of 16 participants - Don't miss out!

Can you answer these FDA questions about your device cybersecurity readiness?

  • Does my device meet the definition of a “cyber device”? Is it subject to this new law?
  • Does your SBOM accurately reflect your complete medical device and its total attack surface?
  • Do you have a post-market vulnerability management plan that includes a patching plan?
  • Does your patching plan align with your commercialization budget for your device?
  • Do you understand how your team will identify known vulnerabilities (as required by the FDA)?
  • Do you know about the common pitfalls that cost undue, unplanned effort & delay?
  • Do you know what you will do if the FDA conducts a post-market inspection of your SBOMs and vulnerability management plan?
  • Do you have a coordinated vulnerability disclosure policy?
Get the MedCrypt advantage and get peace of mind!

Join our former FDA medical cybersecurity team for these answers and more!

Who should join us?

If you are involved in any aspect of developing and maintaining medical devices and managing their security risks, this course is for you!

You do not need to have a background in security. Just be willing to learn and ask as many questions as possible.

What can I expect?

Our team of former FDA medical device cybersecurity policymakers and reviewers will help you to determine the answers to these questions and more.

We’ll take you through each FDA SBOM and vulnerability management plan requirement, discuss how to meet them, answer questions about pitfalls, share best practices, and discuss ambiguous areas of the FDA guidance.

What will it cost?

We’ll be posting more information on this workshop soon, but you can register today to take advantage of our $500 early bird discount, bringing your cost to just $5,000.

Workshop will be limited to 16 participants, and we will share recordings. We may not be able to offer this workshop again, so don’t miss out!

We live and breathe healthcare cybersecurity

A medical device may look like just another IoT device, but regulatory constraints and their unique use case require a healthcare-first approach to cybersecurity. MedCrypt's solutions are built specifically for medical devices, which means clinical functionality, patient safety, and care delivery are always the highest priority.