Medical Device Security — FDA · IEC 62304 · SBOM
Pre-market FDA cybersecurity guidance, IEC 62304 compliance reviews, SBOM generation, and coordinated vulnerability disclosure for medical device manufacturers.
Coverage that goes deep.
Pre-market FDA cybersecurity guidance, IEC 62304 compliance reviews, SBOM generation, and coordinated vulnerability disclosure for medical device manufacturers.
- FDA pre-market cybersecurity submission
- Threat modeling per AAMI TIR57
- Software bill of materials (SBOM) — SPDX/CycloneDX
- IEC 62304 software lifecycle review
- Risk management (ISO 14971)
- Coordinated vulnerability disclosure (CVD) program
- Post-market monitoring strategy
- Timeline
- 20–40 business days
- Methodology
- FDA Pre-market Guidance (2023)
IEC 62304
ISO 14971
AAMI TIR57 - Category
- Offensive
- Re-test
- Included after fixes
Every engagement is led by a CRTO/OSCP-certified senior engineer with named accountability.
What you get back.
A structured deliverable pack you can hand to engineers, auditors and the board.
Cybersecurity bill of materials (CBOM)
Threat model & risk assessment
Pre-market submission package
Coordinated disclosure plan
How we work.
Scope
Confidential scoping call. We agree assets, environments, exclusions and timing.
Test
Active testing per agreed methodology, with daily check-ins on critical findings.
Report
Executive + technical deliverables. CXO presentation if you want it.
Retest
Re-test included after your team applies fixes. Certificate issued on pass.
Common questions.
Are you familiar with FDA submissions?
Tell us about your environment.
A 30-minute scoping call — confidential, NDA-protected, complimentary. Our senior security team will respond within 4 business hours.
- Named senior engineer on every project
- In-house tools in production · ISO 27001 aligned practices
- 4-hour breach SLA · 5–10 day delivery