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We all know the chicken or the egg causality dilemma, often introduced as “what came first, the chicken or the egg?” You could pose a similar question for risk control measures referenced in HF validation tests: What comes first, the verification of use-related risk control measures or the HF validation test?   When to Verify Risk Control Measures | Emergo by UL When to Verify Risk Control Measu..

Historically, the U.S. has been the leader in medical product human factors (HF) engineering maturity with stringent regulatory enforcement, followed by the European Union (EU) with less stringent regulatory enforcement, while most other global regions have had little or no HF guidance or enforcement. However, in the past few years, the global regulatory landscape has continually evolved as othe..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Open Forum: Human Factors Usability Testing Q&A▶ 일시: 2024년 08월 22일 CST 9시 (한국시간: 08월 22일 23시)  Usability testing is one of the most important activities you can perform during the development of your medical device. Usability testing results can help you determine user needs, better understand use-related risks, inform your design process, and demonstrate safer a..

Regardless of a medical product’s complexity, manufacturers have many considerations when it comes to applying human factors during development. Applying human factors to a whole system of medical products versus a singular product might seem even more intimidating. Furthermore, additional complexities might emerge when applying human factors to a system of products where all products or compone..