Medical Writing Artificial Intelligence and Machine Learning Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers
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Volume 32, Issue 3 - Artificial Intelligence and Machine Learning

Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers

Abstract

The implementation of the European Medical Device Regulation (EUMDR) has driven innovation in the digitalisation and the development of artificial intelligence (AI)-powered automations for regulatory writing. This article explores a selection of tools designed for device-related regulatory activities, highlighting their functionalities and use cases. The goals of the article are to demystify the role of AI in medical and regulatory writing, explain the process of developing AI-based automations, illustrate how these tools benefit medical writers, and most importantly enhance the readers’ skills in assessing such tools. The article discusses five automation tools: avasis, DistillerSR, Fern.ai, MedBoard, and Nested Knowledge, providing an overview of their features and benefits. The article concludes by emphasising that these automations address certain pain points faced during medical writing, yet they prioritise different features. By doing so, they empower users to improve data quality and streamline tasks in regulatory writing. Since there is no one-size-fits-all tool, the decision-making process is ultimately that of the user, not only on the type of tool to select but also on how best to leverage the software to optimise their technical documentation.

Medical Writing. 2023;32(3):16–21. https://doi.org/10.56012/hmts9332

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Artificial Intelligence and Machine Learning
From the Editor
President's Message
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Regulatory initiatives for artificial intelligence applications: Regulatory writing implications
Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers
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News from the EMA
Digital Communication
Medical Communications and Writing for Patients
Good Writing Practice
Regulatory Public Disclosure
Regulatory Matters
Getting Your Foot in the Door
The Crofter: Sustainable Communications

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

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 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk