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The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…
The Chinese medical regulatory writing and medical science writing landscapes are chang - ing rapidly. Changes in regulatory reforms continue as China further strives to align its pharmaceutical industry with the world, which necessitates…
Let me start this first editorial in an old journal with a new name by explaining why a medical writing journal has a theme issue on oncology and includes articles that are not directly related to writing. Medical writers write about research that is…
Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…
After the debut of the first edition of this section, I was honoured to be contacted by many aspiring medical writers eager to contribute and to showcase their writing skills. Among them, Matías Rey-Carrizo did anamazing job in translating a complex…
Abstract Regulation plays a fundamental role in the translation of innovative medical devices from concept to clinical application and ensures that only devices that exhibit the highest standards of safety and quality are released onto the EU Single…
Editorial ISO 14155 is an asset for every professional working in the medical device industry. With the new update to this standard, we see improved harmonisation and a clearer guidance to medical device manufacturers who are amidst transition to…
In this release of My First Medical Writing, I have the pleasure to share with you a great article written by aspiring medical writer Shirene Melissa Singh. With over 5 years of experience as a university educator and researcher, she is passionate…
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…
May 2020 was set to be a busy month for medical device writers in Europe. The EU Medical Device Regulation (MDR) was to take effect on May 26, and we were anticipating lively discussions on the final MDR preparations with our fellow writers at the…
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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