Last reviewed: May 1, 2026
Free Guide · Blue Goat Cyber · Updated 2026
CHECKLIST · 1 PAGE · PROSPECT RESOURCE
IP & Data Ownership: Standard Terms Clear boundaries for device IP, data custody, and FDA submission artifacts.
Cybersecurity engagements touch source code, threat models, and submission documents. This checklist is the baseline ownership model we recommend before legal review begins.
Submission artifacts (always client-owned) Threat model, SPDF, cybersecurity risk assessment, and SBOM authored for your device. All FDA-facing deliverables and their underlying source data. Test reports and vulnerability findings tied to your product. Any code or configuration written specifically for your engagement.
Tooling & methodology (consultant-owned, licensed for use) Proprietary scanning, fuzzing, and analysis frameworks. Internal templates, checklists, and review playbooks. Anonymised pattern data used to improve future engagements.
Data handling & retention Data location, encryption, and access-control standards documented in the SOW. Defined retention period for FDA audit-support purposes. Clear deletion procedure once the retention window closes. Confidentiality terms for SBOM and VEX content beyond the engagement.
How to read it. Any deviation from section one (client owns all submission artifacts) is a material risk and should trigger immediate legal review.
NEXT STEP → Request our standard IP & data-ownership clause set to give your legal team a starting point that already reflects MedTech norms. 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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This guide is part of Blue Goat Cyber's MedTech cybersecurity library. To apply it to your device program, book a 30-minute strategy session - no cost, no obligation. Or browse all guides.
