FDA Section 524B compliance for medical device startups.Medical Device Cybersecurity. Start to submission.

MedSecure USA produces the complete FDA cybersecurity documentation package your device submission requires without hiring a full security team.
All 12 documents, fixed pricing, 6–8 week delivery.
Current on the February 2026 FDA Final Guidance.

The problem device startup teams hit too late.

The FDA's updated February 2026 Final Guidance requires a complete cybersecurity file for every connected medical device submission
Missing documentation triggers a Refuse to Accept letter - and your submission doesn't get reviewed until the gaps are fixed.

For any cyber device submission under Section 524B, the FDA expects a complete cybersecurity file including:Security Risk Management Plan (SRMP)
Threat Model & Security Architecture Report
Security Architecture Views (4 required)
Software Bill of Materials - machine-readable (CycloneDX/SPDX)
SBOM Known Vulnerability Assessment
Security Risk Management Report (SRMR)
SOUP / OTS Software Assessment
Penetration Testing Report
Cybersecurity Labeling Additions
Vulnerability Disclosure Policy (VDP)
Post-Market Cybersecurity Monitoring Plan
Coordinated Vulnerability Disclosure (CVD) PolicyMedSecure delivers all 12

Services

Fixed pricing. Scoped to your device and timeline
FDA Cybersecurity Readiness Assessment
SBOM Development & Vulnerability Assessment
Threat Modeling & Risk Assessment
Full Premarket Cybersecurity Package - all 12 documents
QMSR Cybersecurity Alignment Review
Post-Market Monitoring Retainer
Pricing on request.

Why MedSecure USA

The combination of biomedical engineering and cybersecurity credentials is rare in FDA compliance consulting. Most cybersecurity consultants don't understand how medical devices work. Most regulatory consultants don't understand cybersecurity.
MedSecure USA sits at that intersection.
• Current on the February 2026 FDA Final Guidance (GUI00001825) and the QMSR
• Fixed-price engagements scoped upfront - you know the cost before you sign
• Specialists in FDA Section 524B

Book a free 20-minute gap call.
Find out exactly where your cybersecurity documentation stands before your submission deadline does.
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