Cutting-edge technology requires cutting-edge compliance.
We guide you through the evolving regulatory landscape for AI, SaMD, and connected devices. Modern medtech innovation, from AI algorithms to cloud-connected platforms, demands a compliance strategy that evolves as fast as your product. At MethodSense, we help you meet FDA expectations for software transparency, risk controls, and cybersecurity while supporting the technical complexity of adaptive systems and digital tools. We make sure your innovation is safe, validated, and ready for regulatory review.
Develop clinical and performance validation strategies
AI/ML and SaMD require clarity on how performance is measured and validated. We help you define clinical endpoints and performance metrics that support both FDA and EU expectations for digital technologies. Whether you’re working with adaptive learning models, diagnostic tools, or patient-monitoring algorithms, we guide your study design and documentation so reviewers understand what your product does, and why it’s safe.
Related Services
AI/ML Validation & Change Control
Clinical Study Support
Risk Management
- Determine appropriate endpoints and study designs
- Align validation plans with FDA guidance on AI transparency
- Incorporate real-world data and continuous learning models
Integrate cybersecurity into your risk management
Interoperability and device security are regulatory expectations, not extras. FDA’s cybersecurity guidance is no longer optional, and connected device makers must show how security is built into every stage of development. We help you define and document threat controls, align with industry frameworks, and prepare for regulatory review with a complete cybersecurity story.
Related Services
Cybersecurity & Risk Compliance
Cybersecurity & Software Documentation
Regulatory Remediation & FDA Audit Support
- Align documentation with FDA premarket cybersecurity guidance
- Map threat models, control layers, and testing results
- Support SBOM (software bill of materials) creation and maintenance
Document and submit effectively for software-based products
We manage technical files that stand up to reviewer scrutiny. Software-based medical devices require more than code. They require structured documentation that connects your development, risk, and labeling narratives. We build complete submission packages that follow FDA’s SaMD and eSTAR frameworks, ensuring reviewers get what they need, and nothing is left to interpretation.
Related Services
Regulatory Submission Automation & Traceability
Submission Management & Acceleration
LuminLogic Compliance Management Platform
- Structure submissions using FDA’s software and eSTAR checklists
- Ensure alignment between source code, algorithms, and labeling
- Deliver complete documentation packages through LuminLogic®