Cybersecurity for Medical Devices
We provide comprehensive support for ensuring medical devices meet FDA cybersecurity guidance, helping manufacturers navigate regulatory requirements and develop secure, resilient systems throughout the product life cycle.
Cybersecurity risk management
Management of Threat modeling and vulnerability assessment
Management of Software Bill of Materials
Management of Security Testing.
FDA Pre- and Post-market cybersecurity guidance alignment
Secure design and architecture planning
Cybersecurity documentation preparation
Risk mitigation strategy development
Incident response and update mechanisms planning
Support for FDA regulatory submissions
Lifecycle security maintenance strategies
Compliance gap analysis
Stakeholder and cross-functional team support