Get your medical device cleared by the FDA

Navigate cybersecurity compliance for:

510(k) submissions
Pre-market approval (PMA)

Since the release of the latest FDA cybersecurity guidance in October 2023, we’ve helped numerous MDMs achieve a 100% submission approval rate.

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Heightened emphasis on cybersecurity

With the increasing threat of cyberattacks, the FDA has heightened its focus on the cybersecurity resilience of medical devices. To avoid costly delays, eliminate rejections, and reduce post-market repercussions, your submission needs to demonstrate:

Device safety and efficacy
Robustness against cybersecurity threats

Our proven track record

Our team of experts have a deep understanding of the FDA’s cybersecurity expectations. We work closely with you to ensure your submission is meticulously prepared to address every aspect of the guidance.

Naomi Schwartz

Naomi Schwartz

VP of Services
Seth Carmody

Seth Carmody

VP of Regulatory Strategy
Clayton McNeil

Clayton McNeil

VP of Engineering
AJ Reiter

AJ Reiter

Director, Strategy and Organizational Transformation

Get FDA-ready with confidence

Don't leave your 510(k) submission to chance. With our support, you can navigate the complexities of the FDA's cybersecurity requirements and submit with confidence.