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As the authors of this book, Koen Cobbaert and Gert Bos, state “software joins the dots, by connecting patients with healthcare professionals and breaking down the boundaries between everyday objects, medical devices, and medicine.” As a medical…
Medical devices are at the core of healthcare forming a large share of the global healthcare market. With consistent advances in technology, MedTech is enhancing our lives more so now than a few decades ago owing to accelerated digitisation and…
Artificial Intelligence (AI) and machine learning-driven software are evolving toward a technological advancement revolutionising the current global, social, and economic landscape. A major breakthrough in AI is the fast-growing natural language…
Regulatory documents are prepared in a highly collaborative process within tight timelines. The time and the resources required for collecting input, organising document review, and processing the reviewers’ responses often dwarf those invested in…
Canadian and European regulators finalised guidelines that allow for sharing of clinical trial data. To maintain the utility of clinical information, risk-based anonymisation techniques are recommended. It behoves applicants to ensure organisational…
Effective communication is the goal of any professional medical and communication writer. Transferring the correct messages from one language to another is a task that is increasingly covered by software, but translation machines cannot confer the…
The right software can save you a lot of time and make your life much easier. You can choose from a huge range of packages for different medical writing or related activities. It is worth taking a look at what other medical writers recommend to use.…
AbstractIncreased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven.…
In an ideal world, the deluge of information that comes our way from the tax office, insurance com pa nies, lawyers, computer software compa - nies, and suchlike would be written in plain English. Sadly, the reader is often left with the impression…
Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…
Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.
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