Searche

Your search for "regulatory compliance" matched 58 page(s).

Showing results 51 to 58.

New rules for artificial intelligence in Europe - Volume 31, Issue

The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting…

Digital Communication - Volume 33, Issue

Section Editor: Nicole Bezuidenhout Purr-fecting translation: Unleashing the power of computer-assisted translation (CAT) tools Author: Natasha Grande de França Medical translations are fundamental, and precision is at the core of this work. Any…

The Lay Protocol Synopsis: Requirements and feasibility - Volume 32, Issue

The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the…

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),…

Localisation of promotional materials for pharma - Volume 33, Issue

Unwarranted changes by the client, lengthy approvals, and multiple rounds of revision – localisation of promotional materials for pharmaceutical companies can become a nightmare if the localisation specialist is unaware of heavy regulations in the…

Letter from the Editor - Volume 25, Issue

A step – no a leap – forward In 2012, the journal’s precursor, The Write Stuff, became Medical Writing under the guidance of then Editor-in-Chief Elise Langdon-Neuner. The Write Stuff had been managed almost single-handedly by Elise, and the shift…

In this issue of Medical Writing - Volume 23, Issue

Some of you might remember the old days when writing was done with a typewriter, spreadsheets were big pieces of paper, and slides were printed on film. Thanks to computers, these are old memories, and we can all be much more productive. Software…

In this issue… The Medical Writing Business - Volume 24, Issue

As medical writers, we strive not just to survive but to thrive. Threats, opportunities, and complications come from many directions, and how to best position ourselves, our departments, and our companies requires much thought. Money is important…

Visit the EMWA website

Search

Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Scope

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.

Medical Writing is listed in the following indexes: