Human Factors Strategy
User profiles, task analysis, formative planning, and evidence-based design recommendations aligned with IEC 62366 and FDA guidance.
Medical Device Consulting
Human Factors and Quality Management support for submission-critical programs.
Eleanor Williams helps medical device manufacturers reduce use risk, strengthen validation evidence, and improve readiness for Human Factors regulatory review. Support includes Class I, II, and III medical devices, with deep expertise in 510(k) and de novo pathways.
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FDA Approval
Human Factors validation activities guided through FDA approval.
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Class II + III Expertise
Design and execution of robust programs for high-risk medical devices.
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Cross-Functional Leadership
Strong cross-functional communication that drives efficient, aligned progress.
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Deep Domain Coverage
Support for the full spectrum of medical device complexity, from at home health monitoring to complex robotic surgical devices.
Core Consulting Services
Execution support designed for medical device teams under pressure.
Use-Related Risk
URRA, uFMEA and ISO 14971-based risk assessment to surface, prioritize, and mitigate safety-critical use errors before submission.
Validation Study Execution
Protocol design, moderation, data analysis and reporting for validation studies that stand up to regulatory scrutiny in 510(k) and de novo submissions.
Quality Management Systems and CAPA Integration
Build and/or maintain ISO 13485-aligned quality management systems (QMS). Develop and/or maintain CAPA systems using robust root cause analysis to ensure effective corrective action closure.
Cutting-Edge Medical Devices
Human Factors leadership for next-generation device ecosystems.
Innovation programs need Human Factors and quality execution that can keep pace with rapidly evolving technology, multi-system workflows, and global regulatory expectations.
AI Imaging + SaMD
Intelligent imaging and decision-support interfaces
Validation strategy for software user interfaces, alarm handling, and operator-task sequencing in algorithm-enabled imaging environments.
Robotic + Interventional
Complex procedural systems with multi-user workflows
Formative and validation planning for teams operating across physician, technician, and nursing roles in high-acuity settings.
Connected Home Use
Wearables, digital diagnostics, and remote monitoring
Human Factors evidence generation for participant device interaction, onboarding, and sustained use in real-world home environments.
Advanced IVD + Point-of-Care
Laboratory and near-patient diagnostic technologies
Simulated-use and actual-use study execution for sample preparation, workflow reliability, and safety critical task performance.
Simulated Use Environments
Representative use contexts from Human Factors studies.
Simulated-use environments are configured to mirror clinical and home-use workflows, capture use-related risk signals, and generate Human Factors evidence that supports regulatory submissions.
Selected Outcomes
Proven outcomes in regulated environments.
Regulatory-Ready Validation
Led Human Factors validation activities that achieved consistent FDA approval across multiple device categories.
Process Build-Out at Scale
Rolled out Human Factors workflows for assay development and achieved full executive approval and KPI performance.
Quality Transformation
Built ISO-aligned quality frameworks from the ground up, guiding laboratory operations from 0% to 100% compliance.
Regulatory and Standards Alignment
Frameworks and systems your team already needs to satisfy.
- IEC 62366 (Usability Engineering)
- ISO 14971 (Risk Management)
- ISO 13485 (Medical Device Quality Systems)
- ISO/IEC 17025 (Laboratory Competence)
- FDA Human Factors Guidance
- CLIA, CAP, and 42 CFR compliance contexts
Engagement Model
Flexible support for in-flight programs and new launches.
- Interim Human Factors leadership for product teams
- Project-based validation planning and facilitation
- Targeted remediation for submission gaps and deficiencies
- Quality process advisement for CAPA and compliance readiness
Contact
Discuss your next milestone before your next design review or submission date.
Based in Burnet, Texas. Remote and on-site consulting support for medical device manufacturers.