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

Why teams choose us

250+ FDA submissions, zero cybersecurity rejections
Fixed-fee pricing - scoped once, no scope-creep invoices
Aligned to the FDA's February 2026 premarket cybersecurity guidance
Senior MedTech cybersecurity engineer on every call - not an account manager
External perimeter + segmentation testing scoped to the assets your business actually depends on
Findings mapped to CIS Controls v8 so remediation plugs into the framework your team already uses

Get a fixed-fee quote

Free 30-min call · No obligation

Reference

Also in premarket: SOC 2 Penetration TestingMedical Device Penetration TestingDevice Vulnerability & Pen Testing

MedTech segments