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Current Directions in Biomedical Engineering

Joint Journal of the German Society for Biomedical Engineering in VDE and the Austrian and Swiss Societies for Biomedical Engineering

Editor-in-Chief: Dössel, Olaf

Editorial Board: Augat, Peter / Buzug, Thorsten M. / Haueisen, Jens / Jockenhoevel, Stefan / Knaup-Gregori, Petra / Kraft, Marc / Lenarz, Thomas / Leonhardt, Steffen / Malberg, Hagen / Penzel, Thomas / Plank, Gernot / Radermacher, Klaus M. / Schkommodau, Erik / Stieglitz, Thomas / Urban, Gerald A.

CiteScore 2018: 0.47

Source Normalized Impact per Paper (SNIP) 2018: 0.377

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Clinical Evaluation of Mobile Medical Apps

A Process Orientated Guide

Scholtes Michael / Behrend Annemarie / Stephanie Buedenbender / Gross Volker / Sohrabi Keywan
Published Online: 2018-09-22 | DOI: https://doi.org/10.1515/cdbme-2018-0043


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.

Keywords: Mobile apps; Developers’ guide; mHealth

About the article

Published Online: 2018-09-22

Published in Print: 2018-09-01

Citation Information: Current Directions in Biomedical Engineering, Volume 4, Issue 1, Pages 173–176, ISSN (Online) 2364-5504, DOI: https://doi.org/10.1515/cdbme-2018-0043.

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