Regulatory Advice for Medical Device Teams
Human factors and usability engineering guidance for medical device teams navigating submission strategy, documentation, and global regulatory requirements.
Loring Human Factors provides regulatory advice for medical device teams developing human factors and usability engineering strategies that align with FDA expectations, IEC 62366-1, and broader global requirements.
Our work helps clients strengthen HF/UE documentation, identify gaps early, and integrate human factors into product development, risk management, and submission planning.
How LHF Helps
Practical support across HF/UE planning, documentation, and regulatory strategy.
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HF/UE Strategy
Shaping the right HF/UE approach for product risk and submission goals.
Gap Analysis
Reviewing materials and processes to identify readiness gaps.
Submission Support
Preparing HF/UE documentation for regulatory submission.
Response Support
Helping address FDA feedback and any follow-up questions.
Standards Guidance
Advising on FDA expectations and IEC 62366-1 requirements.
Risk Integration
Integrating human factors into design control and risk management.
Where Teams Need Support
Regulatory support tailored to product stage, submission pathway, and existing HF/UE materials.
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FDA Guidance Audits
Reviewing content against current FDA human factors expectations.
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EU MDR & IEC 62366-1
Assessing alignment with international usability engineering requirements.
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Pre-Sub Preparation
Supporting strategy and materials for early regulatory interactions.
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Regulatory Responses
Helping teams respond to agency questions and requests.
HF/UE Program Scoping
Scoping HF work around product risk and submission needs.
Design Control Alignment
Connecting HF activities to design control and risk management.
Built for Submission Readiness
Human factors and usability engineering work is strongest when it is scoped appropriately from the start and aligned with the realities of medical device development.
LHF helps teams build a stronger regulatory strategy by aligning HF/UE activities with product risk, documentation needs, and submission goals. Whether support is needed early in development or in response to agency feedback, our focus is on making the path forward clearer and more defensible.
