SOFTWARE AS A MEDICAL DEVICE
More and more software is used in healthcare or being integrated in products, whether for medical or non-medical purposes. Software is used across a broad range of technology platforms, including medical device platforms, commercial "off-the-shelf" platforms, and virtual networks. But how does software relate to safety certification needed to promote safe innovations and protection of patient safety?
This workshop is an introduction to the development of Software as a Medical device (SaMD), like health apps, decision support software and other medical software not being part of a hardware medical device. The workshop will focus on certification of SaMD according to EU regulations, required standards like IEC 62034 and the needed quality management system. You will learn about user centered design methods to secure usability of the SaMD and how the regulated development process will fit in a scrum/agile framework.
15.45 - 16.00
Registration & coffee
16.00 - 16.10
introduction TechMed Centre
16.10 - 16.15
Status development ad q & a
16.15 - 17.30
Workshop part 1: CE certification of SaMD
17.30 - 18.15
Meet & Eat
18.15 - 19.30
Workshop part 2: User centered design for SaMD
19.30 - 19.45
Exercise on using scrum in SaMD
19.45 - 20.00
20.00 - 20.30
Drinks & End
This knowledge is essential for everybody involved in or responsible for medical device development, both from a technology perspective as from a management perspective. Also it is relevant for everyone who is working on a medical device (prototype/product), such as engineers, researchers, projectleaders.
WHERE & WHEN
- 23 January 2020
- 16.00 - 20.00 (registration from 15.45; drinks after 20.00)
- Entrance: € 30,- (incl VAT) per person
- Language: English
- Location: The TechMed Centre, Technohal (Building 18) - Room TL 2148
University of Twente, Drienerlolaan 5; Route
We welcome a maximum number 30 participants. We will count on your participation for creating working groups and the catering. If you cannot attend the event for which you have already registered, we kindly ask that you let us know. Simply e-mail firstname.lastname@example.org.
THE PURPOSE OF THE TECHMED SERIES
The goal of the TechMed Workshop Series ‘Remove the Barriers to Market Readiness’ is to offer and share knowledge and expertise. The substantive sessions are organized for researchers and (future) entrepreneurs in the medical device industry take place every month. It is the aim of the TechMed Series to bring medical innovations a TRL level further and closer to a successful market introduction. The fee for the workshop series must cover the costs, and are not for profit.
The TechMed Series "Remove the barriers to market readiness" is a one-year-course of workshops for (future) entrepreneurs and scientists in medical technology. The series covers the most important, but also most challenging topics required for the development and production of a safe, reliable and useful medical devices. Following the successes of the past years, we have updated the program to fit your needs on the road to market readiness. During the course of 1 year, 8 sessions are organized, taking place every month on an afternoon and focusing on one specific topic every session. During the sessions, you will work in groups to bring new knowledge to the test. There are no obligations, but we highly encourage you to bring your own case into the discussion! It is possible to attend the complete course, but also separate sessions.
8 INSPIRING SESSIONS
1 of 8
Getting started with your CE mark.
2 of 8
Involving end users in design process.
3 of 8
4 of 8
Software as a medical device.
5 of 8
Clinical evaluation of your medical application.
6 of 8
Prototyping and production of medical devices.
7 of 8
Design verification & validation.
8 of 8
Finding funding for your R&D.
ORGANIZATION & PARTNERS
This session is part of the TechMed Workshop Series ‘Remove the Barriers to Market Readiness’. The events are organized for (future) entrepreneurs in the medical device industry, take place every month on an afternoon and focus on one specific topic every session. By sharing their knowledge and expertise in the TechMed Series the partners aim to bring medical innovations 1 TRL level further and closer to a successful market introduction.
THIS EVENT IS POWERED BY: