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TechMed Series: Risk management in medical devices - Session 3 of 8

SESSION 3: risk management in medical devices

The use of a medical device entails some degree of risk to the patient, but also to the operator, other persons, other equipment or the environment. The process of risk management identifies, evaluates and eliminates or reduces the risks. The standard ISO-14971:2012 is the guidance. It is mandatory to follow this standard, when applying for CE certification. How can you do safety tests on your identified risks in the early stage of R&D, most easiest way, in a simple but controllable environment.

The following topics are covered in this session:

  • Identification of characteristics related to safety.
  • Identification of hazards on electrical safety, biocompatibility or user errors. 
  • Estimation and evaluation of risks.
  • Risk control: measures to eliminate/reduce risk.
  • Residual risk evaluation.
  • Risk benefit analysis. 
  • Analysis of production and post-production information.
  • Documenting risk management in the Design History
  • Easy testing of identified risks in early R&D phase.

detailed prorgamme

3.45 - 4 p.m.

Registration & coffee

4 - 4.10 p.m.

Introduction by TechMed Centre and Holland Innovative

4.10 - 4.20 p.m.

Status development pitches Q/A 

4.20 - 4.50 p.m.

TechMed Talk: Clinical practice and risks - Ruud Verdaasdonk

4.50 - 5.45 p.m.

Workshop part 1: Introduction on risk management, intended use, safety and hazards, risk estimation and evaluation, risk control and residual risk evaluation.

5.45 - 6.15 p.m.

Meet & Eat: Sharing dinner

6.15 - 7.30 p.m.

Workshop part 2: Risk management, design controls, overall residual risk and management report, post design information

7.45 - 8 p.m.

Questions & wrap up

8 - 8.30 p.m.

Networking & drinks


If you are responsible for the development and design of a safe medical device and want to know how to identify and manage the safety risks, this work shop will learn you which tools you need to use and which results you need to deliver in order to comply with the ISO-14971 Risk Management standard.


  • 10 December 2019
  • 4 - 8.30 p.m. (registration from 3.45 p.m.)
  • Entrance: € 30,- (incl VAT) per person
  • Language: English
  • Location: The TechMed Centre, University of Twente, Drienerlolaan 5; Route


Ruud Verdaasdonk
Professor - Health tech implementation

Rudolf M Verdaasdonk is full professor of Health Technology Implementation at the TechMed Centre and staff member the Biomedical Photonics Imaging group at the University of Twente. Before, he was head and chair of the department of Physics and Medical Technology at the Amsterdam University Medical Center (VUmc). He received his MSc in Applied Physics at the Technical University Eindhoven in 1985 and his PhD in Medicine at the University Medical Center Utrecht in 1990. He has been working in University Medical Centers for over 30 years as a registered Clinical Physicist.

His research interest and expertise started with medical laser applications and expanded to a broad range of surgical equipment and imaging modalities. He has developed special imaging techniques for diagnostics and to study the interaction of equipment with the patient in view of safety, treatment quality and development of new applications. His advanced imaging facilities are being used for testing medical equipment of international companies. He is working in close collaboration with the clinical professionals and has practical experience in the OR assisting in surgery with complex technologies. He is active in patient safety, innovation and valorisation of new medical technology with several patents and devices being commercialized. He authored over 150 papers, proceedings and book chapters.

Ton Meek & Karin Ogink Six Sigma Master Black Belt & QA/RA Specialist Medical Devices

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 an 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. More information about Holland Innovative.


The entrance for this session is € 30,- (incl. VAT) per person. If you want you can register for more sessions. Every other session will cost € 30,- (per session). We kindly ask you to pay before the start of the event.  


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 oblications, 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.


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