Vendor Evaluation Grid Checklist

Free Guide · Blue Goat Cyber · Updated 2026

CHECKLIST · 1 PAGE · PROSPECT RESOURCE

MedTech Cyber Vendor Evaluation Grid Selection criteria for a cybersecurity partner that survives FDA review.

A complementary view to the vendor comparison sheet - this grid is framed as scoring criteria you can apply during a formal selection process.

Must-have criteria Documented FDA submission experience for your device class. Senior practitioner named in the proposal and contractually committed. Fixed-fee or capped-fee model tied to enumerated deliverables. AI-letter responses included in the base scope.

Strongly weighted criteria AAMI SW96 / AAMI TIR57 / IEC 81001-5-1 fluency demonstrable in writing. Reproducible threat-modelling methodology, not ad-hoc workshops. SBOM and VEX deliverables in machine-readable formats. Reference customers in the same device class available on request.

Disqualifying signals Inability to show a redacted submission artifact. Open-ended T&M model with no deliverable list. Junior staff handed the work after the SOW signs. No postmarket support pathway under Section 524B(b).

How to read it. A vendor missing any 'must-have' criterion is not a viable premarket partner. A vendor exhibiting any 'disqualifying signal' is a submission risk regardless of price.

NEXT STEP → Book a 20-minute call to walk through the grid with your selection committee. 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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