Innovation Event

Overview

Category: Medtech

Place: BaselArea.swiss, Dufourstrasse 11, 4010 Basel

Adrian Sprenger

Your contact person

Adrian Sprenger

Dr. | Project Manager Entrepreneurship, Medtech


Tel. +41 61 295 50 23

adrian.notexisting@nodomain.comsprenger@baselarea.notexisting@nodomain.comswiss
event Medtech

17.05.2018

Medical Apps: Classification and Challenges of the MDR

The use of health applications on smartphones becomes more prominent every day. According to recent estimates we expect around 1.8 billion smartphone users to download a health application this year. In several cases the distinction between apps used for medical or just for wellness and fitness purposes becomes more difficult. However, this distinction is essential in order to ensure that apps used for medical purposes comply with the corresponding European regulations. By showing practical examples this workshop helps to understand

- when a software application becomes a medical device and

- how to classify software as a medical device under the current Medical Device Directive and the future Medical Device Regulation

Additionally, a brief overview of the key requirements will be provided for software developers falling under the new medical device regulation. The speaker will be also available for additional questions after the official workshop.
 
Date: 17.05.2018
Time: 16:00 – 17:30
Location: BaselArea.swiss; Raum Paracelsus
 

Program

16:00 Welcome Coffee
16:15 Presentation
17:00 Q&A Session


This seminar is free of charge. In case of overbooking, however, innovation-driven projects in the medtech realm are preferred.
 
Please register by email to adrian.notexisting@nodomain.comsprenger@baselarea.notexisting@nodomain.comswiss with the email title “Medical Apps Seminar” and your contact details and a short description of your project in the email body.

 

 

Oliver Hilgers is the Head of the Active Medical Devices Team at CE plus, a regulatory service provider located in Germany. Oliver is an expert for Medical Software/Apps according to the European Directive and looks back on a ten years experience in CE-marking Medical and also In Vitro Diagnostic Devices.

Being a member of several committees for medical software development according to IEC 62304 helps him to discuss the latest trends and software practices and to transfer his experience to the clients. Oliver´s passion is to support software developers to make sure that innovative Medical Software reaches the patient´s computer or smartphone quickly and safely.