Vendor Comparison Sheet Checklist

Free Guide · Blue Goat Cyber · Updated 2026

CHECKLIST · 1 PAGE · PROSPECT RESOURCE

Cybersecurity Vendor Comparison Sheet A diagnostic for evaluating FDA premarket cybersecurity partners.

Use this to compare any two cybersecurity vendors on the dimensions that determine FDA submission outcomes. The criteria deliberately exclude generic IT-security capabilities that do not advance a premarket submission.

FDA submission fit Has the vendor authored eSTAR cybersecurity content for cleared devices?

Can they provide redacted SPDF and threat-model samples?

Do they include FDA Additional Information responses without change orders? Is their work product structured to the FDA's Feb 3, 2026 guidance?

Standards & methodology AAMI SW96, AAMI TIR57, IEC 81001-5-1 fluency demonstrated, not just claimed?

Threat-modelling methodology defined and reproducible?

SBOM and VEX practice aligned with current FDA expectations?

Penetration testing tied to the device threat model, not generic IT?

Engagement & commercials

Fixed-fee submission packages available?

Senior practitioners engaged on the work, not just on the sales call?

Postmarket support pathway defined for Section 524B(b) obligations?

How to read it. A vendor who scores cleanly on the first two sections is a viable premarket partner. A vendor who scores only on the third is selling commercial terms, not submission outcomes.

NEXT STEP → Book a 20-minute call and we'll walk through the comparison with your shortlist. 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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