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TechMed Series: NEW: Software as a medical device - Session 4 of 8

TechMed Series Remove the barriers to market readiness



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.

programme overview

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.


Jolande Koobs-Blankestijn
Project Manager Medical software at Holland Innovative

Holland Innovative

New products need to be as reliable as possible, have the potential to the market quickly, and, above all, they need to meet the expectations and requirements of the customer. Holland Innovative is specialised in Project Management, Product and Process Development and Reliability Engineering. Customers include leading multinationals, Small and Medium Enterprises (SME's) and start-ups. They have a strong desire to do things differently - in a better way. Holland Innovative delivers excellence, experience, the power of implementation and, above all, flexible project managers and experts. 

Jochem Wilson
Senior UX Designer at Panton


Panton is a design studio for healthcare. With the help of design, we want to make health care more intuitive and effective. The care is complex; safe products and processes are desperately needed. there is a need for clarity. we like to think from and with the users. Our goal: thoughtful designs, inviting to use. We are convinced that care with design will become safer and, above all, more fun!

practical information


  • 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


TECHMED SERIES (8 sessions)


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.


1 of 8

Getting started with your CE mark.

More information

2 of 8

Involving end users in design process.

More information

3 of 8

Risk management.

More information

4 of 8

Software as a medical device.

More information

5 of 8

Clinical evaluation of your medical application.

More information

6 of 8

Prototyping and production of medical devices.

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7 of 8

Design verification & validation.

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8 of 8

Finding funding for your R&D.

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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. 

The TechMed Series is a spin-off from the TechMed Proeftuin, an initiative by Holland InnovativeUnitronPanton and the University of Twente