Can a platform replace a pen test?

No. Platforms like Finite State and Cybellum do excellent binary and firmware analysis, but they do not replace a human pen tester probing hardware debug ports, fuzzing medical protocols, or attempting RF and side-channel attacks. The FDA expects both.

Do I need both a services firm and a platform?

Many manufacturers end up with both. A services firm delivers the premarket package and clears the FDA submission; a platform handles continuous postmarket SBOM and vulnerability monitoring across the portfolio. They are complementary, not redundant.

How do I evaluate a cybersecurity provider for a 510(k) submission?

Ask: how many cleared 510(k)s have included their cybersecurity package, what their deficiency-letter rate is, whether they author the submission section themselves (or just hand off a pen test report), and whether they cover hardware testing. The Blue Goat vendor evaluation grid is a starting point.

Who are the major FDA medical device cybersecurity providers?

Services-led: Blue Goat Cyber, MedSec, Velentium, Innolitics, Sekurno (general AppSec). Platform: Medcrypt (SBOM/crypto/monitoring), Cybellum (product security platform), Finite State (binary SBOM), Censinet (healthcare TPRM), CyberMed.ai (AI-driven MedTech security).

Is Blue Goat Cyber a platform?

No. Blue Goat is a services-led firm - no software subscription. We deliver the pen test, threat model, SBOM, and full FDA cybersecurity submission section as scoped, fixed-fee engagements. Many clients pair us with a platform like Medcrypt or Finite State for postmarket monitoring.

Comparison guide

How to Choose an FDA Medical Device Cybersecurity Provider

Q: What is the difference between a services-led firm and a platform vendor?

A services-led firm (Blue Goat Cyber, MedSec, Velentium) authors deliverables - pen test reports, threat models, SBOMs, submission sections. A platform vendor (Medcrypt, Cybellum, Finite State, Censinet) sells software your team operates to generate or monitor those artifacts. The first sells outcomes; the second sells tooling.

A neutral buyer's guide to medical device cybersecurity providers - services-led firms vs platform vendors - and how to choose the right one for an FDA submission.

Quick answer

How do I choose an FDA medical device cybersecurity provider?

Start by deciding whether you need a deliverable or a tool. A services-led firm (Blue Goat Cyber, MedSec, Velentium, Innolitics) authors the cybersecurity submission package and owns it through FDA clearance. A platform vendor (Medcrypt, Cybellum, Finite State, Censinet) gives your internal team continuous tooling for SBOM, vulnerability monitoring, or vendor risk - but the submission is still your job. Most mature MedTech programs end up using both: a services firm to deliver the premarket package, and a platform for ongoing postmarket monitoring. The wrong move is buying a platform when you actually need a deliverable on a deadline.

Sources: FDA premarket cybersecurity guidance (2026); AAMI SW96 standard

The details

Side-by-side breakdown

Dimension	Services-led firms	Platform vendors
Representative vendors	Blue Goat Cyber, MedSec, Velentium, Innolitics, Sekurno.	Medcrypt, Cybellum, Finite State, Censinet, CyberMed.ai.
Primary deliverable	Pen test report, threat model, SBOM, and the full FDA premarket cybersecurity submission section.	Continuous SBOM, vulnerability monitoring, binary analysis, or vendor risk assessments via a SaaS platform.
Owns the FDA submission?	Yes - the firm authors and owns the cybersecurity section through clearance.	No - platform output is consumed by the manufacturer's own submission writers.
Pricing	Fixed-fee or time-and-materials per engagement.	Annual platform subscription, often tiered by device count or user seats.
Hardware pen testing	Most do (JTAG/UART, firmware extraction, RF, side-channel).	Most do not - tools focus on binary, firmware, or SBOM analysis.
MedTech specialization	Varies - Blue Goat is 100% MedTech; Sekurno and many AppSec firms are multi-industry.	Varies - Medcrypt and CyberMed.ai are MedTech-only; Finite State and Censinet serve multiple industries or healthcare broadly.
Best fit	Manufacturers preparing a 510(k), De Novo, or PMA submission and needing the cybersecurity package delivered on a deadline.	Manufacturers with internal product-security teams who need continuous tooling across a device portfolio, or HDOs assessing vendors.

Guidance

When to use which

If you have an FDA submission deadline and no internal cybersecurity team, hire a services-led firm. Tools do not author submissions - people do, and platform output still needs interpretation, mapping to ISO 14971, and integration into the cybersecurity section before a reviewer will accept it.

If you have a mature product-security team and a portfolio of fielded devices, buy a platform for continuous SBOM and vulnerability monitoring. Manual quarterly SBOM updates do not scale past a handful of devices.

If you are a hospital or IDN, your cybersecurity vendor question is different - you need third-party risk management (Censinet) to assess the devices and vendors you are buying, not a manufacturer-side firm.

Cross-check claims. Ask any provider for: number of FDA submissions cleared with their cybersecurity package, deficiency-letter rate, hardware testing capability (JTAG/UART, side-channel), and whether their report has survived an FDA reviewer line-by-line.

FAQ

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