Presentation
Integration of Usability Engineering and Regulatory Compliance in the Medical Device Development Process: Flowchart
SessionPoster Session 2
DescriptionRecently, Regulatory bodies around the world have made usability engineering a mandatory requirement in the approval process of medical devices. Medical device companies face the challenge of complying not only with usability-related standards but also with a variety of international regulations. In particular, start-up companies with less than five years of experience often struggle to develop expertise in usability engineering due to limited resources and personnel, leading to additional costs and delays in obtaining regulatory approval. Furthermore, the difficulty in clearly understanding the interrelationships between various standards has become a major barrier to adopting a systematic approach from the early stages of development. This study aims to propose a guideline that systematizes the stepwise interconnections among relevant international standards, enabling medical device companies to effectively incorporate usability engineering from the early phases of research and development.
This study presents a framework that helps medical device companies integrate Usability Engineering (UE) and Human Factors Engineering (HFE) with quality and risk management systems, rather than treating them merely as regulatory requirements. By visually mapping these interconnections, the framework facilitates a more integrated and efficient development process.
This study presents a framework that helps medical device companies integrate Usability Engineering (UE) and Human Factors Engineering (HFE) with quality and risk management systems, rather than treating them merely as regulatory requirements. By visually mapping these interconnections, the framework facilitates a more integrated and efficient development process.
Contributors
Event Type
Poster
TimeWednesday, October 15th5:30pm - 6:30pm CDT
LocationRiverside East
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