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. Our team of FDA analysts, medical device experts, and cybersecurity engineers are here to help.
The expertise of MedCrypt's specialists can pinpoint gaps and develop a targeted plan to address issues, guaranteeing that the submission meets all requirements for acceptance.
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.
Our expert threat modeling identifies and reduces security issues that impact your FDA readiness and getting your device to market on time.
In the event of an FDA hold letter, MedCrypt provides immediate guidance to navigate the response process effectively.
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
Take a free assessment to gauge your submission readiness with questions aligned with the latest FDA expectations.
Medcrypt’s own FDA expert, Naomi Schwartz, discusses what the new policy means for medical device manufacturers (MDMs) like you.
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Get your secure medical devices to market on or even ahead of schedule, with peace of mind.
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