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BY-NC-ND 3.0 license Open Access Published by De Gruyter September 22, 2018

Clinical Evaluation of Mobile Medical Apps

A Process Orientated Guide

Scholtes Michael, Behrend Annemarie, Stephanie Buedenbender, Gross Volker and Sohrabi Keywan

Abstract

Computer applications in medicine are very important. However, there are differences in quality of such software, which periodically led to discussions about safety, regulation, and registration of software applications. Today, the admission procedure of medical products is highly regulated, and this applies also for mobile medical apps. The clinical evaluation is one important aspect of the admission procedure, especially due to the latest regulatory changes of the guideline MedDev 2.7/1 revision 4. The requirements have increased, and uncertainty grows in medical app development companies. The aim of this paper was the development of a process orientated guide, that gives an overview of the needed steps of a clinical evaluation of mobile medical apps and that could help to give a rough estimation about the necessary effort. The guide was developed, based on the relevant literature and legal texts. The clinical evaluation can be conducted in five substeps: “Planning and Scoping”, “Literature Research”, “Literature Assessment”, “Clinical Data Analysis” and “Reporting”. Prospectively, this guide will be evaluated by developers and adjusted, as soon as Medical Device Regulation is legally binding.

Published Online: 2018-09-22
Published in Print: 2018-09-01

© 2018 by Walter de Gruyter Berlin/Boston

This article is distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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