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Tag Archives | Usability

The New Medical Device Regulation (MDR) and the End User: Supporting Usability Through Documentation

The medtech industry is undergoing significant change, from the introduction of the new MDR to the growth of home-based healthcare and the uncertainties of Brexit. At some recent Irish medtech events, the major topics dominating conversation were: Regulation 2017/745 on Medical Devices – widely known as the MDR Usability and the importance of the end […]

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Medtec Ireland 2017 Conference: How Documentation Supports Usability

The program for the upcoming Medtec Ireland 2017 Conference (Galway, 4–5 October) reflects the increasing focus on the end user in the medtech industry. The Food and Drug Administration (FDA) and international regulatory bodies have recently issued various appeals to pay more attention to usability. This has strengthened awareness in the medtech community of the […]

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Untap the Value of Medical Technology Documentation

Every stage of the medical technology product lifecycle demands detailed documentation. Does it have to be a headache? This post was originally published in September 2016 and updated in September 2017. Unfortunately, the very mention of the term ‘documentation’ can induce instantaneous migraines in Risk and Compliance Officers, Regulatory Affairs Managers, Quality Controllers, and Process Engineers, […]

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