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