Cleared by the FDA, approved by the hospital. Premarket through postmarket, one team, one accountable partner for medical device cybersecurity. Fixed-fee pricing, FDA-ready deliverables.
Start here
Architecture · threats · security controls
Threat model & design support
Pen testing · SBOM · documentation
Evidence for your submission
Reviewer questions · evidence gaps
Deficiency response support
Monitoring · disclosure · updates
Postmarket cybersecurity
Pick a single project, a project followed by ongoing support, or ongoing support from day one.
Short term
A fixed-fee project with a clear scope, such as a penetration test, threat model, or FDA premarket package. You approve the proposal before anything is billed.
Fixed fee after scoping
Short then ongoing
We deliver the project, then stay on to keep your threat model, SBOM, and risk file current through FDA questions, hospital reviews, and new releases.
Fixed fee, then monthly
Long term
A senior advisor who already knows your device, available every week for decisions, reviews, and FDA or hospital questions.
Starting at $5,000 a month
About the MedTech Cybersecurity AdvisoryQuestions about ongoing help before and after clearance? Read the MedTech Cybersecurity Advisory FAQ.
One overview of how Section 524B evidence, submission support, penetration testing, deficiency response, and postmarket monitoring fit together - with pricing and engagement models.
Find your situation, then the services that solve it.
“We need security built in before the FDA asks for it.”
FDA-aligned threat models that identify risks early and speed approvals.
Explore Medical Device Threat ModelingBake cybersecurity into your device from day one.
Explore Secure MedTech Product DesignMore in this area
Also: How this stage works, Weekly advisor (MedTech Cybersecurity Advisory), Free Threat Model Starter
“We need a complete, FDA-ready cybersecurity package.”
One package for applicable FDA cybersecurity documentation, threat modeling, SBOMs, testing, and submission support.
Explore FDA Premarket Cybersecurity PackageFDA-compliant device, firmware, app, and cloud testing.
Explore Medical Device Penetration TestingCreate, validate, and maintain SBOMs for premarket and postmarket.
Explore FDA-Compliant SBOM ServicesMore in this area
Also: How this stage works, Threat model gap assessment, Weekly advisor (MedTech Cybersecurity Advisory)
“The FDA flagged our cybersecurity and the clock is ticking.”
“Hospitals won't buy until we pass their security review.”
One device security program that covers your FDA submission and the security evidence hospital procurement teams ask for, so buyer reviews don't stall your launch.
Explore MedTech Compliance BundlePenetration testing scoped to HIPAA Security Rule expectations.
Explore HIPAA Penetration TestingMore in this area
Also: How this stage works
“We need to stay compliant and handle new vulnerabilities.”
Continuous compliance, monitoring, and vulnerability response.
Explore FDA Postmarket CybersecurityA senior medical device cybersecurity advisor on your team every week, for a fixed monthly fee.
Explore MedTech Cybersecurity AdvisoryReduce risk on fielded devices - no redesign, no new submission, no downtime.
Explore Legacy Device ProtectionMore in this area
“We need to know if the target's cybersecurity will hold up with the FDA.”
Also: Sample executive summary
Continuous SBOM monitoring for medical devices. Daily CVE matching, device-context triage, and VEX-ready evidence aligned to FDA Section 524B - without the noise.
How engagements are scoped, sequenced, and priced - straight answers from a senior team.
"Blue Goat Cyber's depth of expertise was impressive. We had no in-house cybersecurity experience, and their team guided us through every step of the FDA process. The penetration testing and SBOM testing were thorough and gave us complete confidence."
A 30-minute scoping call gets you a recommended package and a fixed-fee SOW - no hourly meters, no surprises.
