Is this aligned with current FDA cybersecurity expectations?

Yes. Static Application Security Testing (SAST) is delivered against the FDA's 2026 premarket cybersecurity guidance, ANSI/AAMI SW96, ISO 14971, IEC 62304, and IEC 81001-5-1 - and structured to land cleanly in eSTAR.

How is the engagement priced and how long does it take?

Fixed-fee, scoped after a free 30-minute Discovery Session. Most premarket engagements (penetration testing, threat modeling, SBOM, deficiency response) complete in 4-8 weeks. We typically start within 1-2 weeks of contract signature.

What if the FDA still pushes back after we submit?

We back our work with a no failed-clearance guarantee. If your submission is delayed because of a cybersecurity deficiency in our deliverables, we resolve it at no additional cost until your device is cleared.

Application Security

Static Application Security Testing (SAST)

Source-code analysis to find vulnerabilities early in the SDLC, with triaged findings mapped to CWE categories and your threat model.

250+ FDA submissions. Zero rejections.

Senior team
Fixed-fee
Reviewer-ready
Re-test included

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Free 30-min call
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Senior expert, not a sales rep
Fixed-fee quote in 24 hours
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Trusted by leading MedTech companies

Reviewed by Christian Espinosa, MBA, CISSP · Founder & CEO

Last reviewed

What's included

Reviewer-ready deliverables in one engagement

Every static application security testing (sast) engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.

Multi-language SAST coverage
Hardcoded credential and secret detection
False-positive triage
CWE mapping and remediation guidance

Relevant standards

Standards this service maps to

Every static application security testing (sast) engagement produces evidence aligned to the regulatory and consensus standards FDA reviewers and notified bodies expect to see - traceable, complete, and ready to drop into your ISO 13485 quality system.

Featured site-wide

SPDF

Secure Product Development Framework

End-to-end secure development lifecycle the FDA expects to see referenced and evidenced in every cyber device submission.

OWASP ASVS

Application Security Verification Standard

Verification requirements for web and application security controls.

FDA 2026 Guidance Featured

FDA Premarket Cybersecurity Guidance (Feb 3, 2026)

Defines the SPDF, Section 524B submission package, threat modeling, SBOM, security architecture views, and cybersecurity testing every cyber device submission must include.

ISO 13485 Featured

Medical Device Quality Management System

International QMS standard for medical devices. Cybersecurity deliverables are designed to slot into your existing 13485 QMS without parallel paperwork.

FAQ