Medical device submissions are built on layers of complex, interrelated documentation, from risk assessments and usability data to clinical evidence and software files. MethodSense helps you structure, manage, and align every component for regulatory clarity and approval success. We offer deep expertise in specialized submission content and the tools to keep everything traceable, accessible, and audit-ready.
Regulatory Submission Automation & Traceability
We simplify submission workflows and improve content quality through LuminLogic’s structured, traceable environment.
Regulatory submissions often involve overlapping documents, multiple contributors, and evolving requirements. We bring structure and automation through our LuminLogic® platform, connecting content to specific regulatory needs while maintaining version control and traceability. The result is a streamlined, transparent submission process that holds up to scrutiny and accelerates approval.
Why MethodSense Matters: We reduce submission errors and improve transparency, accelerating approval timelines.
- Map submission content to regulatory requirements and standards
- Maintain version control, access control, and change history
- Automate content updates and cross-referencing
- Ensure eSTAR and MDR compatibility across your portfolio
Design History & Risk Management
Strong design history files (DHF) and risk documentation are essential for defensible submissions. We help you structure and align your records for agency review.
Design and risk documentation are foundational to your submission story. We help you organize and align these records, from initial inputs to final verifications, ensuring they reflect your product’s evolution and risk posture. Our guidance supports ISO 14971 alignment, seamless traceability, and audit-ready DHFs.
Why MethodSense Matters: We ensure your design and risk story is complete, connected, and submission-ready.
- Organize design inputs, outputs, reviews, and verifications
- Align DHF content with software validation and usability studies
- Develop risk assessments per ISO 14971 and FDA guidance
- Map risk controls to design decisions and labeling
Human Factors & Usability Studies
We guide the integration of human factors testing into your regulatory strategy, especially critical for software, wearables, and home-use devices.
Regulators expect proof that your device performs safely in real-world use. We help you plan, conduct, and document usability testing that supports your submission claims and de-risks your labeling. Whether required by FDA, MDR, or IEC 62366, we ensure your human factors strategy fits your product and audience.
Why MethodSense Matters: We help you demonstrate that your device works safely in the hands of real users.
- Plan and execute usability studies aligned with FDA guidance
- Support IRB approvals and protocol development
- Analyze and document human factors results for submission
- Link findings to labeling, risk, and design requirements
Microbiological & Biocompatibility Support
We provide guidance on sterile device validation and material compatibility documentation to meet both FDA and international requirements.
Sterility and material compatibility are critical for safety, and often scrutinized during review. We help you plan, document, and present test results in a way that supports your submission and reduces the chance of follow-up questions. From test selection to adverse finding mitigation, we ensure you’re aligned with ISO 10993 and beyond.
Why MethodSense Matters: We help you meet the safety expectations behind the most scrutinized parts of your submission.
- Determine appropriate test panels and standards
- Organize test data and lab results for submission
- Address adverse outcomes or incomplete data sets
- Align documentation with ISO 10993 and other global standards
Clinical Study Support
Clinical evidence can make or break a regulatory submission. We help you build a clinical strategy that aligns with both business goals and agency expectations.
Strong clinical evidence adds weight to your claims and accelerates approvals. We collaborate with your CROs and clinical teams to align protocols with regulatory expectations, organize data for review, and close gaps in documentation. Whether you’re collecting primary data or referencing literature, we make sure your evidence tells a clear, defensible story.
Why MethodSense Matters: We help you gather and present clinical evidence with clarity, confidence, and context.
- Plan studies that support specific regulatory claims
- Align protocols with FDA and EU requirements
- Organize and present clinical data clearly and consistently
- Address gaps or inconsistencies before submission
Cybersecurity, AI Performance, Software
Digital devices require specialized documentation to meet fast-evolving guidance. We offer the frameworks and experience to support your innovation.
Software-driven devices come with added documentation demands, from validation plans to algorithm transparency. We help you prepare for scrutiny by aligning with evolving guidance for SaMD, AI/ML, and cybersecurity. Our structured approach connects software development, risk, and regulatory expectations into one clear narrative.
Why MethodSense Matters: We help digital innovators meet high regulatory expectations without slowing down their product development.
- Prepare Software Bill of Materials (SBOM) and threat modeling
- Develop AI/ML performance documentation and change control plans
- Align with FDA’s GMLP, premarket cybersecurity, and SaMD guidance
- Connect software lifecycle documentation to submission and QMS
Risk Management
Risk is central to every regulatory decision. We embed risk management into every layer of your submission and quality system.
Risk isn’t just a document. It’s a throughline that ties together design, labeling, usability, and quality. We help you create and maintain risk management files that reflect your product’s real-world use and regulatory classification. Our risk approach aligns with ISO 14971 and builds confidence in your overall submission and system.
Why MethodSense Matters: We ensure your risk documentation is clear, consistent, and fully integrated with your regulatory strategy.
- Create ISO 14971-aligned risk management files
- Trace risk controls across software, hardware, and labeling
- Integrate risk findings into CAPA and usability studies
- Prepare risk summaries for agency review