FDA Cybersecurity Compliance Made Simple
We help medical device startups and companies get to market quicker by making FDA cybersecurity compliance clear and stress-free.
Cybersecurity Services
Startup Package
Designed for startups and small companies with new medical devices still under design, this service package gets you everything you need to hit the ground running. Learn what the FDA requires in terms of cybersecurity for medical devices. Learn how to design effective cybersecurity controls into your device, and what design decisions could have hidden (and costly) cybersecurity risks.
Submission Support
When submission dates are in the near future, we will help you through the submission process. This package includes review or authoring of threat modeling, cybersecurity controls, security risk assessment, software bill of materials, cybersecurity labeling, architecture diagrams, and post-market planning.
Postmarket Monitoring Package
Security risk doesn't stop when your device receives clearance. We will work with you to create a postmarket cybersecurity plan, including patch management and a coordinated vulnerability disclosure process. Learn how to stay on top of newly-discovered vulnerabilities in your software stack and what the FDA expects in terms of responsible disclosure and patching schedules.
Contact Us
Interested in hearing more? Reach out for additional information or to schedule a free consultation.