Medical Device Security by Design
Cybersecurity embedded into every stage of the medical device lifecycle, ensuring resilient, compliant, and safe products from development through deployment.
Security embedded, not bolted on
Secure software development
Frameworks integrated into your existing quality system, aligned with FDA, EU-MDR, NMPA, and PMDA requirements from day one — not retrofitted before submission.
Medical Device Threat Modeling
Analysis tailored to implantable, diagnostic, and treatment devices, as well as cloud/SaaS-connected products — reflecting how your device is actually built and deployed.
Security Requirements
Security requirements defined alongside product requirements from day one, so security is scoped and traceable rather than inferred after the fact.
Security risk management
Risk assessment across both development and post-market phases, integrated with your broader safety risk management process rather than run as a separate track.
AppSec Integration
Application security (AppSec) tooling automated within your CI/CD pipelines, catching issues as code ships instead of in a pre-submission scramble.
Cross-functional collaboration
We work directly with your engineering, quality, and regulatory teams, so security decisions match how your organization actually builds — not a process bolted on from outside.
Security touchpoints across your device lifecycle
Modeled on the industry's total-product-lifecycle approach to device security (the same thinking behind HSCC's Joint Security Plan) — security travels with the device from first sketch through the field, and what's learned post-market flows back into the next design.
Architecture & Design
Threat modeling and security requirements defined alongside product requirements, not after them.
Development
Secure coding practices and automated AppSec tooling integrated into your existing pipelines.
Verification & Validation
Security testing incorporated into your V&V process, mapped to submission requirements.
Deployment & Post-Market
Risk management continues after launch, feeding into post-market surveillance.
↩ Field data & post-market findings feed back into the next design cycle
Building a device right now?
The earlier security is part of the conversation, the less it costs to get right — tell us where you are.