Threat Detective

Threat Detective is SBOM and vulnerability management software built for medical device teams. It turns vulnerability analysis into submission-ready cybersecurity evidence and keeps that evidence current through post-market surveillance. Core capabilities include: - SBOM ingestion and validation: Accepts CycloneDX and SPDX format SBOMs, checks them against regulatory expectations, and flags gaps before submission. - Vulnerability identification: Scans SBOM components against three vulnerability databases, surfaces findings in a triage queue, and allows users to prioritize by risk and exploitability. - Documentation generation: Produces FDA eSTAR sections, EU Notified Body summaries, and QMS-ready reports directly from the platform, removing the need for manual spreadsheet assembly. - Post-market surveillance: Continuously monitors deployed software versions for newly disclosed CVEs, sends daily alerts for Critical and High severity findings, and tracks annual review obligations required by regulators. The platform is priced per device rather than per seat, with three tiers: Pre-Market (focused on submission preparation), Post-Market (adding continuous monitoring), and a Private Cloud option with SSO and data residency controls. Hosting is available in EU, US, or UK regions. Threat Detective was created by Alan Parkinson, who built the tool to address the gap between generic SBOM tooling and the specific documentation requirements of medical device regulatory submissions. The product targets medical device manufacturers navigating pre-market clearance and ongoing post-market compliance obligations.