Archive | Medical Technology

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 and the update to ISO 13485, to the growth of home-based healthcare and the uncertainties of Brexit. This post was originally published in November 2017 and updated in March 2018. At some recent Irish medtech events, the major topics dominating conversation were: […]

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The Continued Relevance of Dekker’s “Field Guide to Understanding Human Error”: From Blame Culture to Safety Culture

When investigating a workplace accident, you might be inclined to believe that the employees involved should automatically be held responsible for the unfortunate incident. If so, you are taking what author Sidney Dekker describes as “the old view” of human error. Taking this old view, as the book reveals, will do little to prevent further […]

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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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What Story Does Your Process Documentation Tell?

Good process documentation tells the story of an organisation. All businesses are comprised of sets of interrelated processes, the reliability and repeatability of which hinges on the quality of the process documentation. We’d like to share some insights on how strengthening the narrative of your organisation’s processes can help you achieve your business goals. This […]

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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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User-Centred Health Communications: Techcomm and the Public Good

Good health is essential to us all. When we experience poor health or need guidance to improve it, we rely on healthcare providers to assist us. The healthcare industry is obligated to ensure that the communications about the products and information it provides, from packaging and labelling to instructions for administering drugs or using devices, […]

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