About

Built by someone who's been there.

Threat Detective was born from too many late nights staring at spreadsheets that pretended to be systems—tracking SBOMs across device versions, manually crosswalking CVEs to risk files, and reformatting developer outputs into something a Notified Body wouldn't throw back with polite teeth.

The Problem

The weight of proving, not just doing.

The problem wasn't understanding cybersecurity—it was proving it to regulators. We had devices in the field running different firmware versions, legacy builds in clinics that couldn't sync their upgrade schedules, companion apps two versions behind. Each one needed continuous surveillance, exploitability assessments, and audit trails linking SBOMs to CVEs to risk decisions.

The tools I tried fell into two camps: enterprise platforms that hid compliance features behind “contact sales” walls and NDAs, or developer-centric scanners that handed me JSON dumps and called it “regulator-ready.” Neither understood that medical devices aren't rolling web deployments. Neither gave me what a Notified Body actually wanted to see.

I was angry—not dramatically, but constantly. Angry at vendors treating clarity as a premium upgrade. Angry at myself for duct-taping spreadsheets into a “process” that wouldn't survive me taking a day off. Mostly, I was tired of being the bottleneck between good engineering and market access.

The Solution

Evidence that stands on its own.

Threat Detective treats each deployed version as a first-class citizen—not an afterthought. Legacy builds in clinics get the same continuous monitoring as your current release. When a CVE drops, you see exactly which versions are affected, capture exploitability decisions with clear rationale, link to risk files, and generate reports that look like what Notified Bodies and FDA reviewers actually want to see.

No enterprise theater. Pricing is transparent: per device, same features, available today. No “contact sales” gates hiding the basics. Reports come out formatted for MDR Annex I, MDCG 2019-16, IEC 81001-5-1, and FDA submissions—ready to drop into your technical file without midnight reformatting sessions.

The goal isn't to make you a cybersecurity expert. It's to give you a defensible, repeatable process that proves continuous surveillance without spreadsheet acrobatics. So you can focus on building safe devices instead of becoming the formatter of last resort.

Our Approach

Principles that guide everything we build.

No enterprise theater

Per-device pricing you can see today. No “contact sales” games, no feature gates, no NDAs just to learn what things cost. If you can't evaluate it this week, it's not transparent.

Version-aware from day one

Medical devices aren't rolling web apps. Legacy builds in clinics deserve the same monitoring as current releases. Every version is a first-class citizen, not an afterthought.

Regulator-ready, not developer-ready

Reports formatted for Notified Bodies and FDA reviewers from day one. No midnight copy-editing sessions to translate JSON dumps into submission language. Evidence over theater.

Exploitability with rationale

Not just “is it exploitable?” but why, under what conditions, with what compensating controls. Capture decisions the way auditors ask for them: traceable, defensible, linked to risk files.

PMS that doesn't drown you

Continuous surveillance without constant panic. Alerts tuned for signal, not noise. Weekly triage that feels like hygiene, not a hostage situation.

Built by someone who's sat in reviews

Support from people who understand MDR Annex I, MDCG 2019-16, and IEC 81001-5-1—not just software. We speak auditor, not just developer.