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This article introduces four documents associated with the new Medical Device Regulation 2017/745: the clinical evaluation plan, post-market clinical follow-up (PMCF) plan and PMCF evaluation report, and the summary of safety and clinical…
Switzerland is practically unknown in the drug/medical device regulatory landscape despite being home to some of the world's biggest pharmaceutical firms. This article briefly describes the regulations governing clinical trials in Switzerland and…
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…
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…
A free and open-source software tool is presented that facilitates the analysis and the visualisation of data in basic life science. Daniel's XL Toolbox is an add-in for the Microsoft Excel® spreadsheet software. It enables scientists to store…
The production of high-quality graphical figures of scientific data is an important aspect of medical writing, since the significance of the research findings can be lost to the audience if the data are presented poorly or inaccurately. This…
The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…
Microediting aims to ensure consistency aswell as accuracy within a document and across a document series. Also known as technical editing or mechanical editing, it is an important stage in editing, needed to gain and retain a reader’s interest and…
Advances in software and its application in a medical device and as a medical device have opened the door for many new technological capabilities in healthcare. Around the globe, government agencies have begun to take a heightened interest in how…
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…
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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