2019年 1月 30日

인간 공학 집중 조명: 아동이 혼자서 의료기기를 사용해도 될까요?

EMERGO BY UL 핵심 요약: 대상 사용자에 아동이 포함되는 의료기기 제조사는 의료기기를 설계할 때 관련 인간 공학 및 사용 편의성 문제를 고려해야 합니다. 미성년자를 대상으로 하는 의료기기 회사는 안전하고 효과적인 사용을 보장하기 위하여 아동의 작업 기억 용량과 관련된 문제를 수용해야 합니다.
2019年 1月 30日

人間工学への注目: 子どもは医療機器を自分で操作すべきでしょうか?

EMERGO BY UL キーポイントのまとめ: 対象とされるユーザーが子供を含むメーカーは、医療機器を設計するときに関連する人間工学的要素とユーサビリティの問題を考慮に入れなければなりません。 製造する機器が未成年を対象とする企業は、安全性と効果的な使用を保証するために子供の作業記憶容量に関する問題に対応しなければなりません。
2019年 1月 30日

Spotlight on Human Factors Engineering: Should kids be operating medical devices independently?

EMERGO BY UL SUMMARY OF KEY POINTS: Manufacturers whose intended users include children must consider pertinent human factors and usability issues when designing their medical devices. Issues pertaining to working memory capacity in children should be accommodated by companies whose devices target minors to ensure safe and effective use.
2018年 7月 8日

Balancing Aesthetics and Usability in Medical User Interface Design: 9 Key Trends

As the influence of technology in our everyday lives continues to grow, the standard for aesthetically pleasing and contemporary user interface (UI) designs in the healthcare space continues to evolve.
2018年 7月 8日

Balance zwischen Ästhetik und Bedienfreundlichkeit beim medizinische UI-Design: 9 wichtige Trends

Die Technologie beeinflusst unser Leben immer weiter. Die Standards für ästhetisch ansprechende und zeitgemäße Benutzeroberflächen (UIs) im Gesundheitswesen entwickeln sich dementsprechend ebenfalls weiter.
2018年 3月 13日

AAMI Webinar on HFE Reports for Medical Device Manufacturers

A new webinar hosted by the Association for the Advancement of Medical Instruments (AAMI) will provide insights into preparing Human Factors Engineering (HFE) test plans and reports that existing regulatory guidance does not fully address.
2018年 2月 6日

8 Key Steps to Delivering Effective, In-person Medical Device Training

For some medical devices used in clinical and home environments, end-users are the benefactors of formal training designed to facilitate safe and effective device use. However, not all medical device training programs are created equal.
2018年 2月 6日

提供有效的医疗器械现场培训的8个关键步骤

对于在临床和家庭环境中使用的某些医疗器械来说,其终端用户是以提高医疗器械使用安全性与有效性为目的的正式培训提供者。但是,并非所有的医疗器械培训项目都拥有相同实施水平。
2018年 1月 10日

英国在医疗器械人因工程方面的立场更为严格

Emergo重点摘要: 英国MHRA的人因工程(HFE)指导性文件在某些方面与欧盟颁布的建议有所区别。 MHRA建议意见的关注重点在于医疗器械开发过程中的HFE和可用性工程。 在某些领域里,MHRA指导性意见比欧洲标准更接近美国FDA的建议意见。
2018年 1月 10日

UK Takes Stricter Stance on Human Factors Engineering for Medical Devices

EMERGO SUMMARY OF KEY POINTS: Human Factors Engineering (HFE) guidance from the UK MHRA differs in some areas from recommendations issued by the European Union. The MHRA focuses its recommendations on HFE and usability engineering during medical device development. In some areas, the MHRA guidance hews closer to US FDA recommendations than European standards.

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