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Suzanne Halliday, D.Phil., is the Vice President for Regulatory within the Notified Body BSI with extensive experience in compliance to the Medical Devices Directive (MDD), ISO 13485, risk management, clinical evaluations and investigations, meeting…
Abstract The inherent differences between medical devices and drugs have implications for clinical research and medical writing. In view of the current move to more stringent regu - latory requirements for the medical device industry, an increasing…
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…
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…
Translation for medical devices often presents a unique set of challenges arising from the products’ complex natures and associated regulatory requirements. Beyond medical expertise, linguists – from translators and editors to bilingual quality…
Abstract Compliance with European regulatory standards in animal research could be viewed as a way of dotting the i’s and crossing the t’s, rather than actually holding the research to scientific scrutiny. Standardisation is important and needs…
The role of medical affairs in pharmaceutical and medical device companies is gaining prominence. Medical writers will increasingly find themselves supporting medical affairs activities or, indeed, transitioning to jobs within medical affairs…
The quest for transparency in the relationships between life sciences companies and healthcare professionals is quickly becoming a global movement. Reporting requirements for financial interactions have been prevalent in the United States for many…
Discussion with writers from all walks of life and from across the globe has revealed that we have all come to our chosen career through different pathways. Furthermore, writer jobs are highly variable; two medical writers may have completely…
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 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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