Coordinated Vulnerability Disclosure (CVD)
Coordinated Vulnerability Disclosure (CVD) is now table-stakes postmarket evidence: the FDA's 2016 postmarket guidance, the 2026 premarket guidance, AAMI TIR97, and ISO/IEC 29147 + 30111 all expect a published, monitored intake channel and a documented triage/remediation process. This hub pulls together our CVD policy, the services that stand it up, the postmarket guides that wrap around it, and the standards reference - so you can ship a CVD program reviewers can audit, not a security.txt file no one watches.
Services
- FDA Postmarket Cybersecurity
Once cleared, your device still needs eyes on it. We handle SBOM monitoring, coordinated vulnerability disclosure, patching, and FDA-aligned reporting - delivered as one-off projects or as an annual TPLC Partnership covering an entire product line.
- Postmarket SBOM Monitoring & VEX Automation
Operational postmarket cybersecurity for cleared medical devices: continuous SBOM diffing against NVD/CISA-KEV/OSV, automated VEX triage, CVE-to-patient-harm risk scoring, and CAPA-ready evidence packs - aligned with FDA postmarket guidance, ANSI/AAMI SW96, and ISO 14971 risk management.
- Legacy Device Protection
Compensating controls, network isolation, and monitoring for fielded devices that can't be easily updated - keeping clinical operations running without touching the cleared design.
- Full-Service FDA Premarket Cybersecurity
Full-service, end-to-end: we deliver 100% of the artifacts FDA reviewers expect for 510(k), De Novo, PMA, and IDE submissions - traceable, complete, and aligned with current 524B guidance.
In-depth guides
- Postmarket Cybersecurity Readiness PlanA three-phase plan — Premarket → Launch → Operate — for the cybersecurity work that starts before your 510(k) is filed, lights up before your first device ships, and runs for the life of the product. Aligned to the FDA February 2026 final guidance.
- SBOM Vulnerability Management for Medical DevicesMaster SBOM vulnerability management for medical devices. Learn to track, triage, and mitigate software risks to meet FDA premarket and postmarket requirements.
- VEX Document Guide: FDA Medical Device ComplianceLearn how VEX documents complement SBOMs for FDA medical device compliance. Expert guidance on Vulnerability Exploitability eXchange for MedTech manufacturers.
- The MedTech Cybersecurity Standards DecoderA plain-English field guide to FDA Section 524B, IEC 81001-5-1, AAMI TIR57, ANSI/AAMI SW96, ISO 14971, and 8 more medical device cybersecurity standards — what they require, how they connect, and what FDA expects in your eSTAR premarket submission.
Standards & guidance
Defined entries from our MedTech Cybersecurity Standards Glossary.
- AAMI TIR57Principles for Medical Device Security – Risk ManagementThe MedTech-specific extension of ISO 14971 for cybersecurity. Defines how to identify cybersecurity assets, threats, and vulnerabilities, then estimate, evaluate, and control the resulting risk.
- FDA 2026 GuidanceFDA Premarket Cybersecurity Guidance (Feb 3, 2026)The FDA's final premarket cybersecurity guidance, effective February 3, 2026. Defines the seven-section cybersecurity submission format reviewers now enforce at Technical Screening, replacing the 2023 draft. Operationalizes Section 524B of the FD&C Act.
- SPDFSecure Product Development FrameworkA documented framework that shows security activities are integrated across the device lifecycle - not bolted on at the end. Includes secure requirements, threat modeling, secure coding, V&V, vulnerability management, and post-market response.
- NIST CSF 2.0Cybersecurity FrameworkSix functions: Govern, Identify, Protect, Detect, Respond, Recover. Not MedTech-specific, but commonly used by health-system customers as their procurement bar - so device makers need to map their controls to it.
- ISO 13485Medical Device Quality Management SystemThe international QMS standard for MedTech. Covers design controls, document control, CAPA, supplier management, and post-market surveillance. The QMSR final rule (effective Feb 2, 2026) harmonizes 21 CFR Part 820 with ISO 13485.
From the blog
- Postmarket Cybersecurity for Medical Devices: The FDA RoadmapFDA clearance is the beginning of your cybersecurity obligations, not the finish line. Postmarket cybersecurity for medical devices is an active, continuous requirement that most manufacturers underestimate until a problem forces their hand. Most invest significant resources building premarket docum
- Medical Device Cybersecurity: SBOM & SASTSBOM + SAST explained: learn how component transparency and static code scanning strengthen medical device cybersecurity, align with FDA guidance, and cut risk.
- The Importance of Medical Device Vulnerability TestingLearn why medical device vulnerability testing is crucial for patient safety and data security.
Related FDA deficiencies
The deficiency letters reviewers most often write on submissions in this topic area. Each links to the full response playbook.
- Missing Security Architecture Views
Your submission is missing one or more of the architecture views FDA 2026 expects (global system, multi-patient, updateability).
Response playbook - Insufficient Penetration Testing Evidence
Reviewers find your penetration test scope too narrow, methodology unclear, or testers insufficiently independent.
Response playbook - Inadequate Vulnerability Management Plan
Your VM plan lacks defined triage timelines, a coordinated vulnerability disclosure path, or a documented patch-deploy mechanism.
Response playbook - Insufficient Secure Boot Evidence
Reviewers want test evidence that secure boot, signed updates, and root-of-trust controls function as claimed.
Response playbook
Coordinated Vulnerability Disclosure (CVD) - frequently asked questions
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