Deep Expertise, Delivered with Precision.
At MethodSense, compliance strategy is only half the equation. We also deliver. Our team of senior consultants, engineers, and quality specialists knows how to translate complex regulations into action, helping you avoid missteps and get it right the first time.
Our work spans a wide range of disciplines across regulatory strategy, quality systems, software compliance, clinical research, and lifecycle documentation, each powered by experience, process, and the LuminLogic® platform.
Regulatory Affairs
From initial regulatory strategy to complete submission management, our team brings years of hands-on experience navigating global pathways like 510(k), De Novo, PMA, and EU MDR. We don’t just advise. We lead submissions, manage agency engagement, and resolve regulatory hurdles with precision.
- Develop strategic regulatory roadmaps across global markets
- Craft and execute Pre-Sub strategies for Q-Sub success
- Prepare and manage 510(k), De Novo, and PMA submissions
- Navigate complex EU MDR requirements and Notified Body feedback
- Address cybersecurity, AI, and risk documentation requirements
Quality Systems & Risk Management
An effective quality system doesn’t just check boxes. It enables growth and ensures compliance. We build and optimize QMS programs tailored to your size, products, and global footprint. From internal audits to CAPAs, we make sure quality supports your success.
- Design and implement ISO 13485-compliant QMS programs
- Conduct supplier audits and manufacturing compliance assessments
- Draft, revise, and harmonize SOPs across product lines
- Lead CAPA investigations and process remediation
- Integrate risk management into product lifecycle (ISO 14971)
- Provide on-call QA support for lean teams
AI/ML & Software Compliance
Digital health technologies demand modern compliance strategies. Whether you’re developing SaMD, AI/ML-powered tools, or connected devices, we guide you through software lifecycle documentation, cybersecurity validation, and FDA/IEC expectations.
- Build IEC 62304-compliant software documentation packages
- Prepare software bill of materials (SBOMs) and threat models
- Validate cybersecurity controls in alignment with FDA guidance
- Document AI/ML performance and predetermined change control plans
- Support SaMD lifecycle, labeling, and usability alignment
Clinical & Usability Studies
Successful submissions are supported by evidence. We help clients design clinical trials and usability studies that align with FDA expectations while generating actionable insights. From IRB coordination to endpoint selection, our team ensures you gather the right data the right way.
- Develop human factors study protocols and regulatory justification
- Coordinate IRB submissions and usability study execution
- Align clinical strategy with risk, indication, and predicate claims
- Plan studies to support regulatory and market access goals
- Organize and present clinical data with clarity and consistency
Lifecycle Documentation & Submission Execution
Regulatory success depends on consistent, traceable, and audit-ready documentation. We manage content development, version control, and submission assembly using our structured methodology and the LuminLogic platform.
- Organize and align DHFs, risk files, and labeling content
- Automate traceability matrices and document workflows
- Manage timelines and contributor coordination for FDA eSTAR, MDR
- Prepare complete submission packages across global jurisdictions
- Address submission gaps, RTAs, and audit findings with precision