Read on the page or download the full PDF. Each playbook is built from real submission and remediation work - not theory.
What changed in the Feb 3, 2026 final premarket cybersecurity guidance, what reviewers now expect, and a 90-day path to a fully aligned submission.
How to generate, validate, and continuously update a CycloneDX SBOM with VEX statements that survives FDA review and powers your postmarket program.
STRIDE-per-element + AAMI TIR57 methodology, a device-specific threat checklist, an attack-tree template, and the traceability matrix reviewers want.
A turn-key blueprint for standing up an FDA-aligned Coordinated Vulnerability Disclosure program: policy, intake, triage SLAs, advisories, and reviewer-ready evidence.
End-to-end field guide for generating, validating, distributing, and operating SBOMs for embedded, mobile, SaMD, and hybrid medical devices.
How to bring fielded legacy and end-of-support medical devices up to current FDA expectations without a full re-architecture - compensating controls, remediation tiers, and customer communications.
Plain-English guide to the cybersecurity expectations of EU MDR Annex I, IVDR Annex I, MDCG 2019-16, and the upcoming Cyber Resilience Act - plus how to harmonize an FDA + EU package.
How to build a Predetermined Change Control Plan for AI/ML SaMD that survives FDA review - and how to threat-model the model itself (poisoning, inversion, adversarial inputs, prompt injection).
30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.
