Medical Device Cybersecurity Regulatory Compliance
Guidance through complex, ever-changing global cybersecurity regulations — so your submissions clear the bar the first time, not the third.
Compliance guidance built around your quality system
Cybersecurity requirements differ by market, and clearing one doesn't guarantee clearing another. FDA's Section 524B, the EU's MDR and incoming Cyber Resilience Act, China's NMPA, and Japan's PMDA each define their own expectations for documentation, risk management, and testing evidence — with real differences in scope, format, and timing.
Gap assessments
Your current program evaluated against the specific markets you're targeting — FDA (US), EU MDR/CRA, NMPA (China), PMDA (Japan), and other applicable expectations — with a clear, prioritized list of what's missing before you file, not after a deficiency letter.
Documentation & policy templates
Policies, procedures, and document templates aligned to your existing quality system, not bolted on as a generic afterthought that doesn't match how your team actually works.
IEC 81001-5-1 & ANSI/AAMI SW96 alignment
Bring your health software security practices in line with these standards' lifecycle and risk management requirements, integrated into the development process you already run.
HIPAA Security Rule compliance
Analysis and guidance for devices and systems that touch protected health information, alongside your device-specific cybersecurity requirements.
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 package fits your stage?
Tell us where you are in the submission process — we'll recommend the right starting point.