의료기기 이야기

[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...

[EU] MDCG 2024-15 - Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)

1. Introduction Article 77(5) MDR requires that the sponsor submits to the Member States in which a clinical investigation was conducted a clinical investigation report within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, irrespective of the outcome of the clinical investigation. Furthermore, the clinical investigation report..