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Regulatory Advice
Manufacturers often need expert advice on scoping a Human Factors / usability engineering program for a device or system. LHF has extensive experience helping clients, especially those in the medical and pharmaceutical industries, implement tailored programs that meet the requirements of IEC 62366-1 and the FDA (US). We often help clients prepare materials for Pre-Sub meetings and respond to FDA feedback and regulatory questions. By keeping up with the latest standards and guidance, we can help you avoid costly delays due to inadequate HF/UE data.
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Regulatory Roadmap for HF
Services:
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EU MDR and IEC 62366-1 gap analysis
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FDA Guidance audits
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HF/UE strategy development
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Review of responses from regulatory bodies
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Integration of HF into existing design control & risk management processes
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