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Human Factors Methodology In Medical Device Design For FDA Approval


by: Sean Hägen

image url: 2022/08/375_250-istock_1140779754_lab_team_research_equipment.jpg

Human factors engineering (HFE) must be considered by every medical device manufacturer at some phase of the design and development journey to ensure the end product can not only gain FDA approval but also meet the needs of the users and patients. The regulatory risk classification, level of potential harm associated with the use of the device, and product complexity are general determinants for the scope of HFE involvement.

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