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 Plan
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 prcoess. 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.
Templates and Training
If your engineering or quality and regulatory teams have a DIY spirit but are unsure where to start, we can get you set up with document templates, training, and draft reviews.
Fractional Product Security Officer
For companies who are looking for dedicated cybersecurity personnel but don't want additional full-time headcount, we are able to provide consistent and effective cybersecurity services on an on-going basis.
Custom Services
We provide a range of cybersecurity risk services, from third-party software risk evaluation, setting up a CVE pipeline, to reviewing cloud and backend components. Contact us with any questions.