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Section Editor: Payal Bhatia Mastering the art of the state of the art (under EU MDR 2017/745) Author: Clotilde Jumelle Establishing the state-of-the-art (SOTA) represents a crucial aspect of a clinical evaluation under the European Medical…
The Medical Device Regulation (MDR) mentions the term “Clinical Development Plan” (CDP) only twice, both of which are in than the MDR into what the CDP entails and to propose the best strategies for a manufacturer to plan their medical…
MEDDEV 2.7/1 is the European guideline about the clinical evaluation of medical devices. The 4th revision, in 2016, updated how clinical evaluation should be conducted and reported, thus paving the way for clinical evaluation under the Medical…
Plain language summaries (PLSs) of clinical trial results are vital tools in the clinical development process for enhancing transparency and encouraging and facilitating patient engagement. The production of a PLS is now mandated in the EU for all…
Section Editor: Payal Bhatia EMWA’s medical device expert seminar series brings together speakers with different expertise providing valuable insights into the medical device industry. Medical device Expert Seminar Series: Beyond traditional…
Medical communicators can choose words that influence how people perceive individuals and populations who take part in research. For many years, the term subjects was used ubiquitously and internationally in clinical research. However, this term can…
In this Medical Writing issue on Translation, we explore the transformative role of translation in advancing medical communications and improving access to healthcare. Translation is the intricate process of converting the written word from one…
This article discusses the challenges and quality assurance measures implemented by the authors when translating medical reports. In particular, the authors discuss the challenges posed by acronyms, handwritten and scanned text, and desktop…
Section Editor and Author: Sam Hamilton Medical Writing. 2024;33(3):95–100. https://doi.org/10.56012/vhdv1639
In an age of increasing digitisation, pharmaceutical product information is evolving. This transformation reflects growing recognition among regulators of the value of patient engagement and widespread societal calls for increased transparency of…
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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