Is this aligned with current FDA cybersecurity expectations?

Yes. Internal 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 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.

Network & Infrastructure Testing

Internal Penetration Testing

Simulates a malicious or compromised insider to test segmentation, monitoring, and privileged access controls inside your environment.

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
NDA available on request

Trusted by leading MedTech manufacturers since 2014 · See client outcomes and awards

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

Last reviewed

What's included

Reviewer-ready deliverables in one engagement

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

Assumed-breach scenarios
Privilege escalation and persistence
Segmentation validation
Detection and response evaluation

Relevant standards

Standards this service maps to

Every internal 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

NIST SP 800-115

Technical Guide to Information Security Testing

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

NIST CSF 2.0

Cybersecurity Framework

Govern, Identify, Protect, Detect, Respond, Recover - the lingua franca for cybersecurity program maturity.

HIPAA Security Rule

Protected Health Information Safeguards

Administrative, physical, and technical safeguards for ePHI handled by covered entities and business associates.

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