Under current FDA Premarket Submission Cybersecurity guidance, sponsors must demonstrate structured cybersecurity risk management, secure product development processes, threat modeling, SBOM transparency, vulnerability monitoring, and post-market response planning.

This is not optional.

And it is not limited to new devices.

Previously cleared products are increasingly being re-evaluated against modern cybersecurity expectations, especially where software updates, connectivity changes, or AI components are introduced.

Our Cybersecurity Compliance Gap Analysis Toolkit provides a structured framework to assess your current posture against FDA expectations and international standards.

You gain clarity on where you stand before regulators do.

Start a Cybersecurity Gap Analysis

Our toolkit evaluates:

• Secure Product Development Framework (SPDF) alignment

• Threat modeling and risk documentation

• SBOM completeness and transparency

• Vulnerability monitoring processes

• Patch and update governance

• Secure configuration management

• Post-market cybersecurity response planning

We provide a written gap assessment with prioritized remediation guidance — tailored to both new submissions and legacy products requiring re-review.

This transforms cybersecurity from a documentation burden into a defensible engineering discipline.

For teams requiring deeper support, we offer hands-on cybersecurity review and remediation.

We work directly with engineering and quality teams to:

• Rebuild cybersecurity risk documentation

• Strengthen threat modeling frameworks

• Align technical controls with regulatory expectations

• Integrate cybersecurity into design controls and change management

• Prepare documentation for FDA review

Whether preparing for a new 510(k), De Novo, or PMA submission or proactively strengthening previously cleared software we help you establish structured, defensible cybersecurity governance.

Cybersecurity is now a regulatory expectation.
We help you meet it with confidence.