Medical Writing Medical Devices A beginner´s guide to writing clinical investigation plans and reports for medical devices
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Volume 31, Issue 2 - Medical Devices

A beginner´s guide to writing clinical investigation plans and reports for medical devices

Abstract

A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of  the statistical analysis. A clinical investigation report should summarise the plan, explain any deviations from it, and present and discuss the results of the clinical investigation. Preparing clinical investigational documents requires collaboration with numerous professionals with expertise in clinical practice, statistics, data management, monitoring, and regulatory requirements. While separate guidelines apply for medical devices and pharmaceuticals, with differences in terminology and safety reporting among other factors, they offer similar guidance on good clinical practice, adapted for the product type. As a medical writer, you should not be afraid to ask questions when things are unclear, or to offer input.

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Incoming President's Message
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Foreword from the European Commission
Differences between writing for medical devices and pharmaceuticals: An update
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Winner of the Geoff Hall Scholarship Essay Competition
Biotechnology
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
Lingua Franca and Beyond
My First Medical Writing
News from the EMA
Pharmacovigilance
The Crofter: Sustainable Communications
Regulatory Matters
Regulatory Public Disclosure
Veterinary Medical Writing

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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 ChangZuo 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