Is this aligned with current FDA cybersecurity expectations?

Yes. Application Penetration Testing 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 100% success 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

Application Penetration Testing

Comprehensive application penetration testing across desktop, mobile, web, and APIs - including manual source-code review when in scope.

250+ FDA submissions. Zero rejections.

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

Book Strategy Session

Free 30-min call
No obligation
Senior expert, not a sales rep
Fixed-fee quote in 24 hours
NDA available on request

Trusted by leading MedTech companies since 2014

Reviewed by Trevor Slattery, OSCP · COO

Last reviewed May 2026

What's included

Reviewer-ready deliverables in one engagement

Every application penetration testing engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.

Thick and thin client testing
Mobile and web application coverage
API security assessment
Manual source-code review

Relevant standards

Standards this service maps to

Every application penetration testing 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

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.

ANSI/AAMI SW96 Featured

Medical Device Security Risk Management

The consensus standard for medical device security risk management - asset, threat, vulnerability, likelihood, severity, and residual risk acceptability.

NIST SP 800-115

Technical Guide to Information Security Testing

Reference methodology for planning, executing, and reporting security testing.

FAQ