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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: Conducting a Comparative Analysis in Lieu of HF Validation Testing▶ 일시: 2024년 05월 09일 EST 10시 (한국시간: 05월 09일 23시)  A common way to conclude whether a product can be used safely and effectively as intended by the intended users in the intended use environment is to conduct a human factors (HF) validation test. However, it might be appropriate and acceptable ..