MedSecure USA
FDA Compliance ToolsHTMwire assessment
MedSecure USA is a consultancy specializing in FDA Section 524B premarket cybersecurity documentation for medical device manufacturers. It produces a fixed-price package of the 12 documents a cyber device submission requires, including the Security Risk Management Plan, threat model and security architecture, machine-readable SBOM and vulnerability assessment, penetration test report, labeling, and vulnerability disclosure policies, with a stated 6 to 8 week delivery. The buyer is the device manufacturer preparing an FDA submission, so for hospital HTM teams this is manufacturer-facing context rather than a direct purchase.
Key Features
- ✓ Fixed-price full premarket cybersecurity package (all 12 Section 524B documents)
- ✓ FDA cybersecurity readiness assessment
- ✓ SBOM development and known-vulnerability assessment (CycloneDX/SPDX)
- ✓ Threat modeling and security risk management (SRMP/SRMR)
- ✓ Penetration testing report, VDP/CVD policies, and post-market monitoring plan
What It Helps You Do
What Sets Them Apart
A fixed-price, productized FDA Section 524B premarket package delivering all 12 required cybersecurity documents in a stated 6 to 8 week window.
How MedSecure USA Uses AI
HTMwire's independent read on the technology — not the vendor's marketing claim.
Key Numbers
- ▪ 12 documents per Section 524B package
- ▪ 6 to 8 week delivery
Tags
Frequently Asked Questions
Is MedSecure USA for hospitals or medical device manufacturers?
It is for medical device manufacturers and device sponsors. FDA Section 524B applies to premarket submissions by manufacturers, not hospitals, so MedSecure USA's package is manufacturer-facing and only contextually relevant to hospital HTM teams.
What is in MedSecure USA's FDA Section 524B package?
A fixed-price set of all 12 documents a cyber device submission requires, including the Security Risk Management Plan, threat model and security architecture, machine-readable SBOM and vulnerability assessment, SOUP/OTS assessment, penetration test report, labeling additions, vulnerability disclosure and coordinated disclosure policies, and a post-market monitoring plan.
How is MedSecure USA priced and how fast is delivery?
MedSecure USA advertises fixed pricing scoped upfront and a stated delivery window of 6 to 8 weeks for the full premarket cybersecurity package.
Is MedSecure USA current with the latest FDA guidance?
The company states it is current on the February 2026 FDA Final Guidance (GUI00001825) and the QMSR, and describes itself as a specialist in FDA Section 524B.
Sources
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