Security expertise for every stage of the device lifecycle
From first threat model to post-market surveillance — practical, regulator-ready cybersecurity support for medical device and health IT manufacturers.
Regulatory Compliance Consulting
Guidance on complex global cybersecurity regulations to ensure devices meet stringent security standards — FDA, EU MDR, NMPA, and PMDA.
- Gap assessments against current regulatory expectations
- Documentation and policy templates aligned to your quality system
- HIPAA Security Rule compliance analysis
- IEC 81001-5-1 alignment for health software
Security by Design Services
Cybersecurity embedded into every stage of the medical device lifecycle, ensuring resilient, compliant, and safe products from development through deployment.
- Secure software development frameworks integrated into your quality system
- Comprehensive threat modeling for implantable, diagnostic, treatment, and cloud/SaaS products
- Security risk management across development and post-market phases
- Cross-functional collaboration with engineering, quality, and regulatory teams
Application Security & Testing
Enhance device protection through automated scanning and comprehensive penetration testing, led by industry experts.
- Automated security tooling deployed within CI/CD pipelines
- Industry-expert-led penetration testing
- Post-market surveillance: vulnerability monitoring, risk assessment, regulatory reporting
Choose the level of support your program needs
Essentials
For startups
Gap assessments, recommendations, and ready-to-use policy and document templates to get your security program off the ground.
Ask about this packageStandard
For FDA / MDR preparation
Risk management, threat modeling, document drafting, and security testing review to prepare a submission-ready package.
Ask about this packageComprehensive
For full lifecycle support
Everything in Standard, plus independent security testing and hands-on regulatory support through submission.
Ask about this packageNot sure which service fits?
Tell us about your device and timeline — we'll recommend the right starting point.