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뉴스 보고서 72

[Emergo, UL] What Does it Mean for a Device to be Inherently Safe by Design?

Both the FDA’s Human Factors Engineering (HFE) guidance and the global HFE standard IEC-62366 list “inherent safety by design” as the most effective method of managing use-related risks associated with medical devices. In this article, we discuss what is meant by safety by design, provide examples of products that demonstrate it and explore how it can be implemented within medical device design...

뉴스 보고서 2024.12.18

[Emergo, UL] When to Verify Risk Control Measures as Part of Human Factors Engineering Activities

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..

뉴스 보고서 2024.12.16

[Emergo, UL] MHRA Opens Public Consultation on Proposed Changes to Medical Device Regulatory Framework

BackgroundFollowing the 2021 government consultation on changes to the Medical Devices Regulations 2002 (MDR 2002), and now armed with even more information and experience, on Nov. 14, the U.K. medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a public consultation. The MHRA solicited members of the public, including patients, medica..

뉴스 보고서 2024.12.03

[Emergo, UL] MHRA Proposes International Reliance Route for Medical Devices

BackgroundAs noted in a previous Regulatory Update, the Medicines and Healthcare products Regulatory Agency (MHRA) has opened a public consultation on proposed changes to the medical device regulatory framework in GB. This includes the introduction of a new framework that would allow certain medical devices authorized by other countries to be placed on the GB market without needing a UKCA (U.K. ..

뉴스 보고서 2024.11.28

[Emergo, UL] Webinar: The Role of AI in the Practice of Human Factors Engineering

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: The Role of AI in the Practice of Human Factors Engineering▶ 일시: 2024년 11월 20일 CST 9시 (한국시간: 11월 21일 00시) During this webinar, the presenters will briefly discuss the various medical technologies that incorporate AI features and/or machine learning. However, the focus will be on how AI of the chatbot variety can facilitate a wide range of analyses and writing eff..

뉴스 보고서 2024.11.17

[Emergo, UL] What the MDCG regulatory guidance document regarding ethylene oxide covers

It has caused years and years of regulatory uncertainty: Which EU law regulates ethylene oxide (EtO) used for sterilization of medical devices? At least for medical device and IVD manufacturers, this should be clear by now, with the publication of “MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the sterilization of medical  devices”.  What the MDCG document regulating steril..

뉴스 보고서 2024.11.15
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