Medical Writing Artificial Intelligence and Machine Learning Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers

Volume 32, Issue 3 - Artificial Intelligence and Machine Learning

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


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,, 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.

Download the full article



Artificial Intelligence and Machine Learning
From the Editor
President's Message
Regulatory initiatives for artificial intelligence applications: Regulatory writing implications
Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers
AI language models are transforming the medical writing space – like it or not!
Narratives for a clinical study report: The evolution of automation and artificial intelligence
Unlocking new efficiencies: How structured content authoring is streamlining the production of clinical documents for the pharmaceutical industry
Can readers spot the AI impostor in healthcare writing?
Essential principles towards improving clinical risk assessment tools: A conversation with Uri Kartoun, PhD
AI-based plagiarism detectors: Plagiarism fighters or makers?
A survey on current use of software tools for systematic literature reviews
Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics
AI for medical writers: Friend or foe?
Introducing EMWA’s new AI Working Group
Diversity in clinical trials: It takes a village
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


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

Editoral Board


Raquel Billiones


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


Jennifer Bell


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

Maddy Dyer


Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha


Tiziana von Bruchhausen


Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk