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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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FDA's HF Diagram
Services:

  • EU MDR and IEC 62366-1 gap analysis 

  • FDA Guidance audits

  • HF/UE strategy development

  • Review of responses from regulatory bodies 

  • Integration of HF into existing design control & risk management processes

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