Is this aligned with current FDA cybersecurity expectations?

Yes. Web 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 no-cost deficiency resolution commitment. If your submission is delayed because of a cybersecurity deficiency in our deliverables, we resolve it at no additional cost until that deficiency is closed. We cannot and do not guarantee clearance itself - that is the FDA's decision.

Application Security

Web Application Penetration Testing

OWASP-aligned web application testing covering authentication, session management, business logic, and API integrations.

The short answer

What does a web application penetration test cover?

A web application penetration test checks the parts of a web app a user or attacker can reach: login and session handling, access control between users and roles, input handling (injection and cross-site scripting), business logic and the APIs behind the pages. For MedTech clinician portals and patient apps, it also checks how patient data is exposed and protected.

275+ devices supported. No cybersecurity-related rejections to date.

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

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Reviewed by Christian Espinosa, MBA · Founder & CEO

Last reviewed

What's included

Reviewer-ready deliverables in one engagement

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

OWASP Top 10 and ASVS coverage
Authentication and session testing
Business-logic abuse cases
Linked API and mobile coverage

Also in premarket: SaMD CybersecurityAPI Penetration TestingMedical Device Penetration Testing

MedTech segments