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Even though in vitro diagnostic medical devices (IVDs) occupy only a very small market segment in the healthcare sector, they have a vital role to play. The importance of diagnostics was strongly underlined during the COVID-19 pandemic. In the EU,…
Abstract The new Medical Device Regulation (MDR) has recently been approved, and after a transition period of 5 years, all medical devices will be approved and marketed according to these new regulations. This article compares the main changes of…
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.…
Nanotechnology, the manipulation of matter on a molecular scale, is all around us in our everyday lives. Chocolate, non-dairy creamer, and sunscreen are examples of consumer products with a high content of nanoparticles. Nanotechnology holds great…
Insulin was first purified in 1921 by Frederick Grant Banting and Charles Herbert Best at the University of Toronto. Soon after, the benefits of using insulin to treat diabetes was discovered, the patent was sold to the University of Toronto for $1,…
Abstract Training: Lessons in self-leadership Kathryn E. White (author), Zuo Yen Lee (section editor), Clre Chang (section editor) More often than not, freelancing means juggling between running a business and writing. Training may not be at the…
Unwarranted changes by the client, lengthy approvals, and multiple rounds of revision – localisation of promotional materials for pharmaceutical companies can become a nightmare if the localisation specialist is unaware of heavy regulations in the…
Section Editor: Kimi Uegaki Breaking barriers in sustainable development in East Africa: How Lightup Impact is leveraging communications to shift the power to the right actors Authors: Nicole Bezuidenhout, Valeria Santoro, Jeniffer Muganda …
Pharmaceutical regulatory medical writing for document submissions to Western health regulatory agencies has been undertaken in India for almost 10 years. From humble beginnings in a couple of non-Indian pharmaceutical multinational giants –…
Dear Editor, EMWA and other organisations (eg, AMWA, ISMPP) support the principles of Good Public at - ion Practice (GPP). As a co-author of the recent GPP3 guideline1 and leader of the professional medical writer section, I was concerned by a…
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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