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.
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Explore service PremarketMachine- and human-readable SBOMs with NTIA minimum elements (superseded by CISA's 2026 Minimum Elements for an SBOM, published July 29, 2026), vulnerability mapping, and end-of-support tracking - built for FDA review.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 PostmarketCompensating controls, network isolation, and monitoring for fielded devices that can't be easily updated - keeping clinical operations running without touching the cleared design.
Explore serviceFree 30-minute strategy session with a senior MedTech cybersecurity expert. No cost, no commitment.
