MedTech Cybersecurity Partner Evaluation Checklist

Free Guide · Blue Goat Cyber · Updated 2026

CHECKLIST · 1 PAGE · PROSPECT RESOURCE

MedTech Cybersecurity Partner Evaluation Checklist An IT security consultant who has never written an SPDF will not get you cleared.

Generic IT security firms can run a penetration test. Very few have ever drafted a Secure Product Development Framework (SPDF), responded to an FDA Additional Information request on cybersecurity, or mapped AAMI TIR57 onto an ISO 14971 risk file. Use this to separate the two.

FDA submission experience How many 510(k) or De Novo submissions has the vendor authored cybersecurity sections for? Have they responded to an FDA Additional Information (AI) request on cybersecurity in the last 24 months? Can they show a redacted SPDF, threat model, or VDS from a cleared device? Are their deliverables structured for the eSTAR cybersecurity attachments, not generic IT reports?

Standards depth Do they work natively in AAMI SW96, AAMI TIR57, and IEC 81001-5-1, not just NIST CSF? Can they integrate cybersecurity risk into an ISO 14971 risk management file? Do they understand SBOM (CycloneDX/SPDX), VEX, and Coordinated Vulnerability Disclosure obligations? Are their threat models written to the FDA's Feb 3, 2026 guidance, not a generic STRIDE template?

Engagement model Do they offer fixed-fee submission packages, or only time-and-materials? Do they stay engaged through FDA review without change orders for AI-letter responses? Are senior practitioners on the engagement, or is the work handed to junior staff after the SOW signs?

How to read it. If a vendor cannot answer the FDA submission experience section concretely, treat them as an IT vendor adjacent to MedTech, not a MedTech cybersecurity firm. The two paths produce very different review outcomes.

NEXT STEP → Book a 30-minute reference call to review redacted submission artifacts and confirm fit before signing an SOW. Book your discovery call: go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session

Page 1 · © Blue Goat Cyber · 250+ FDA submissions, zero rejections, since 2014

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