Regulatory requirements that bend to your workflow.
Fixed-price FDA and IVDR cybersecurity documentation with clear explanations, honest assessments, and engineering-first delivery.
What we do
Engineering-focused compliance services that deliver clear, submission-ready documentation.
Cyber Submissions Package
Fixed-rate deliverables covering FDA clearance and EU MDR/IVDR compliance. Includes threat model, SBOM narrative, vulnerability process, and all required documentation. FastTrack available.
View detailsCVD Hosting
Coordinated Vulnerability Disclosure endpoint for your customers, with regulatory notifications and remediation support — hosted in your brand.
View detailsGap Analysis
Full traceability analysis of your cybersecurity package against FDA, ISO 81001-5-1, and MDCG 2019-16 with a prioritized findings report.
View detailsHow it works
A straightforward, transparent process from assessment to submission.
Assess
We review your device, architecture, and regulatory targets. You get a clear scope and fixed price — no surprises.
Build
We produce submission-ready documentation: threat models, SBOM narratives, vulnerability processes, and compliance artifacts.
Support
One year of post-market cybersecurity support included. Vulnerability monitoring, disclosure coordination, and regulatory updates.
Standards & frameworks
We work across the full landscape of medical device cybersecurity requirements.
Built by engineers who've shipped regulated software.
Not consultants who've only reviewed it. We've built SaMD, navigated FDA submissions, and contributed to the standards we help you implement.
Tools & resources
Practical tools for medical device cybersecurity compliance.
VexTriage
Free, browser-based VEX vulnerability triage editor. Zero dependencies, client-side only, no tracking. Supports CSAF, OpenVEX, CycloneDX, and SPDX formats.
RegRadar
Regulatory intelligence platform tracking FDA guidance updates, deficiency patterns, and emerging trends across global medical device authorities.
BMI Plus
Interactive walkthrough of how medical device regulation shapes SaMD development — from prototype to submission-ready, with 72 linked regulatory documents.
Let's talk about your device.
Tell us about your device, your timeline, and your regulatory targets. No sales pitch — just a straightforward assessment of what you need.