Medical Writing Medical Devices
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Volume 31, Issue 2 - Medical Devices

June 2022

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Editorial

Editorial
Authors: Kelly Goodwin Burri, Namrata Upadhyay

EMWA 30 years and 53 conferences later
Author: Raquel Billiones

President's Message

Incoming President's Message
Author: Satyendra S. Shenoy

Outgoing President's Message
Author: Carola Krause

EMWA News

EMWA News
Author: Somsuvro Basu

Foreword from the European Commission
Authors: Ana Eva Ampelas, Mario Gabrielli Cossellu

Feature Articles

Differences between writing for medical devices and pharmaceuticals: An update
Authors: Roderick Mallia, Beate Walter

Implantable medical devices: Preclinical testing in new product development – on the road to clinical reality
Author: Monica L. Meyer

EU sourcing requirements for animal-derived materials
Author: Russell T. Kronengold

The clinical development plan
Author: Namrata Upadhyay

A beginner´s guide to writing clinical investigation plans and reports for medical devices
Author: Jessica Norberg

Clinical evaluation reports: 6 years after the introduction of MEDDEV 2.7/1 revision 4
Author: Gillian Pritchard

Post-market clinical follow-up insights
Authors: Laura C. Collada Ali, Katharina Friedrich, Gillian Pritchard

The periodic safety update report and post market surveillance report under the new EU Medical Device Regulation
Authors: Karelia E. Tecante, Andre Sokija

New rules for artificial intelligence in Europe
Author: Kirsten Dahm

How the EU Medical Device Regulation is affecting the medical device landscape. An interview with Suzanne Halliday, the Regulatory Head of BSI, Medical Devices Notified Body
Authors: Carmen Giefing-Kröll, Geneviève Laumen

Optimizing the value of regulatory writers
Authors: Dylan Harris, Lisa Chamberlain James, Julia Forjanic Klapproth, Brian Bass

Value of medical writing: The regulator's perspective
Authors: Julia Cooper, Lisa Chamberlain James, Joan Affleck, Brian Bass

Value of medical writing: The regulatory writer's perspective
Authors: Dylan Harris, Cathy Tyrrell, Amy Myers, Cynthia Carr, Karen L. Fink

Special Section

Winner of the Geoff Hall Scholarship Essay Competition
Authors: Sampoorna Rappaz, Lisa Chamberlain James

Regular Sections

Biotechnology
Authors: Ahmad M. Nazzal, Jennifer Bell

Getting Your Foot in the Door
Authors: Virginia Chachati, Ivana Turek

Good Writing Practice
Authors: Michael Lewis Schneir, Wendy Kingdom, Amy Whereat

In the Bookstores
Authors: Lisa Chamberlain James, Alison McIntosh, Stephen Gilliver

Lingua Franca and Beyond
Authors: Yateendra Joshi, Maria Kołtowska-Häggström

My First Medical Writing
Authors: Sibyl Bertrand, Evguenia Alechine

News from the EMA
Author: Anuradha Alahari

Pharmacovigilance
Authors: Arthur Jarov, Tiziana von Bruchhausen

The Crofter: Sustainable Communications
Authors: Gomotsegang Fred Molelekwa, Kimi Uegaki

Regulatory Matters
Authors: Tiago Silva, Joan D’souza, Zuo Yen Lee, Clare Chang

Regulatory Public Disclosure
Author: Sam Hamilton

Veterinary Medical Writing
Authors: Caroline Chambers, Elissa Burnside, Louisa Marcombes

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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:

Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Brooks Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir

AI/Automation

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Adriana Rocha

Freelancing

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Pablo Izquierdo / Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Tiziana von Bruchhausen

Pharmacovigilance

Clare Chang / Zuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Jeff Blair / Luiza Ventura

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk