Is this aligned with current FDA cybersecurity expectations?

Yes. Network 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

Network Penetration Testing

External and internal network penetration testing to measure exposure, validate controls, and prioritize hardening.

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

External perimeter testing
Internal lateral-movement scenarios
Active Directory abuse paths
Risk-prioritized remediation plan

Relevant standards

Standards this service maps to

Every network 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.

IEC 62443-4-1

Secure Product Development Lifecycle

Industrial-strength secure-development-lifecycle requirements applied to connected medical devices.

MedTech segments