Medcrypt cybersecurity readiness services

Optimizing your path to FDA cybersecurity readiness.

We partner with you to ensure your devices can achieve the highest level of regulatory review, as well as develop cybersecurity programs that scale with you.

Get your secure medical devices to market on or even ahead of schedule, with peace of mind.

Get peace of mind

We understand how quickly the security landscape is changing, and how important it is to your business and patients to ensure the maximum probability of regulatory approval. Contact us to learn how we can help with:

FDA Cybersecurity Filing Readiness Survey

A free assessment for MDMs to gauge submission readiness by responding to survey questions aligned with the new FDA guidance, including RTA. This service provides valuable insights into the risks to acceptance for the submission.

FDA Cybersecurity Filing Remediation

For MDMs who do not pass the FDA Filing Readiness Survey or face an FDA refusal, MedCrypt's experts can help identify gaps and create a prioritized plan to rectify issues, ensuring the submission becomes acceptable.

FDA Cybersecurity Submission Readiness

Designed for MDMs with submissions either already under FDA review or planned for the near future, this service offers a comprehensive review using MedCrypt's unique five-sector framework (review of threat modeling, post-market management, vulnerability management, security risk assessment, and SBOM processes and outcomes) to ensure cybersecurity compliance.

FDA Cybersecurity Hold Letter Response

In the event of an FDA hold letter, MedCrypt provides immediate guidance to navigate the response process effectively.

How long do I have to fix these issues?

You need to start working on your remediation plan today to avoid any unexpected delays.

The FDA will issue its final guidance in September. As of October 1, 2023, the FDA will start sending Refuse to Accept responses to any medical device manufacturers who have not submitted the requisite strategy and documentation to show that their device is secure today and that they have a plan to maintain that security throughout the lifecycle of the device.

Contact us today so we can help navigate potential pitfalls to ensure that your FDA submission is complete.

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What does Refuse to Accept mean to me?

The FDA is moving forward with its authority under the new section 524B of the FD&C act.

This means that it is now a requirement for medical device manufacturers to:

  • build your device to be secure by design
  • develop strategies to monitor and maintain the security of that device throughout its lifecycle
  • generate the requisite documentation proving you’ve built a secure device and have a plan to maintain that security