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Intelligent use of artificial intelligence for systematic reviews of medical devices - Volume 28, Issue

Systematic literature reviews are an essential component of the medical device clinical evaluation process. The EU Medical Device Regulation requirement for regularly updated systematic literature searches will increase the burden on the medical…

Medical Devices - Volume 29, Issue

The Medical Devices Regulation (MDR 2017/745) has been postponed due to the coronavirus pandemic and will now take effect on May 26, 2021.1 Some manufacturers may regard this as a slight breather, but there are still enough obstacles to overcome.…

CME in the Deutsches Ärzteblatt and the development of multiple choice questions for medical educational purposes - Volume 25, Issue

Continuing medical education (CME) in Germany, as in other countries, is an estab - lished instrument for the delivery of ongoing training in medicine. Since September 2004, Deutsches Ärzteblatt has published 155 CME papers, and, as of the 12th of…

Making the leap: My move from academia to medical writing - Volume 28, Issue

A complete re-evaluation of your career path can be a daunting task. By identifying your own key skills, a proactive approach can be taken. Talking to varied companies and people in the field and trying out different writing styles can help to find…

REACH chemical dossiers? Yes, please! - Volume 23, Issue

Medical writing knowledge and skills can be applied relatively easily to other areas of technical regulatory writing, with a bit of home study. One such area is in the compilation and write-up of REACH (Registration, Evaluation, Authorisation, and…

Teaching Medical Writing - Volume 32, Issue

Co-development, co-delivery, and evaluation of a Medical Writing module at master’s level Few universities offer courses in medical writing, and students from the biomedical sciences who wish to become medical writers typically need to learn…

Lessons from building an accredited medical conference: Design and delivery - Volume 25, Issue

Participation in meetings and events by healthcare professionals is part of their continuing professional development, and it is a requirement for organisers to gain accreditation for continuing professional development in order to attract…

HTA decision-making: Do ethics matter? - Volume 30, Issue

Before reviewing the article in this issue of Medical Writing by Larry Liberti and Tina Wang, The regulatory-HTA decision-making interface: What the medical writer should know (p. 50), I put on my ethicist’s hat. Thus, I tuned my ethics antennae to…

What medical writers need to know about regulatory approval of mobile health and digital healthcare devices - Volume 28, Issue

The rapid growth of mobile health (mHealth) led to the development of internationally harmonised guidance for software as a medical device (SaMD) by the International Medical Device Regulators Forum (IMDRF), covering definitions, risk…

Post-market clinical follow-up insights - Volume 31, Issue

The EU Medical Devices Regulation (MDR) brought about new post-market clinical follow-up (PMCF) requirements for medical devices. Whereas complaint monitoring and literature searches were often sufficient under the Medical Devices Directives (MDD),…

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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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