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, high lighting 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, provid ing 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.