Postmarket cybersecurity that keeps your cleared device compliant
Cleared and prepping to launch - or already in the field
FDA's postmarket expectations are not optional. Vulnerability monitoring, SBOM upkeep, coordinated vulnerability disclosure, and patch validation have to be live before the first device ships - and stay live for the device's lifetime. We stand up the program, run it with you, or take it over entirely.
How we move you through postmarket
- Continuous SBOM monitoring with VEX evidence and CVE matching
- Coordinated Vulnerability Disclosure (CVD) program aligned to AAMI TIR97
- Patch validation and re-testing on each material release
- Postmarket reporting reviewers and customers actually trust
Services that fit this stage
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.
Explore service PremarketFDA-Compliant SBOM Services
Machine- and human-readable SBOMs with NTIA minimum elements (superseded by CISA's 2026 Minimum Elements for an SBOM, published July 29, 2026), vulnerability mapping, and end-of-support tracking - built for FDA review.
Explore service PostmarketLegacy 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.
Explore serviceReady to take on postmarket?
Free 30-minute strategy session with a senior MedTech cybersecurity expert. No cost, no commitment.