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TechMed Workshop Series - Training: Fundamentals of medical device development

This event is "sold out"

The try-out training

As a member of a medical device development project team you collaborate with a wide variety of experts from different fields in the project or program within your organization. The development process is a journey that starts with an idea and ends with a medical device that is safe, suitable for the intended use, and CE certified (by a notified body). This course Fundamentals Medical Product Development will illuminate the development process and show you how the expertises Regulatory, Reliability, Design for Six Sigma and Project Management work together as a team to successfully complete the design of the intended medical device.

detailed overview


08.45 - 09.00

Registration & Welcome

09.00 - 12.30

Regulatory, standards, QMS 

Introduction to the regulatory requirements for CE certification of your medical device.

12.30 - 13.30

Lunch break

13.30 - 17.00

Design for Six Sigma

Market CTQs, internal CTQs, MSA.


End of day 1


08.45 - 09.00


09.00 - 12.30

Design for Six Sigma

Reliability, V&V.

12.30 - 13.30

Lunch break

13.30 - 17.00

Project management

Project management in medical product development.

17.00 - 17.30

End of the training & Drinks


  • Engineers and (project) leaders in medical device organizations who are tasked with managing and executing medical device projects, project teams and regulatory/engineering activities.
  • The course is suited for professionals with a master or bachelor level, or equivalent knowledge gained through experience.
  • Affinity with product development processes and medical device development is required.
  • The training is only for those who had individual case support during the TechMed Proeftuin (Living Lab). Those who had this support will get an invitation for this training.  

where & when

  • Tuesday 23 and Wednesday 24 April 2019
  • 09.00 – 17.00 (start program at 09.00) (both days)
  • Free entrance (including drinks and lunch)
  • Language: Nederlands
  • Carré 3.022, Auditorium ECTM
  • University of Twente, Drienerlolaan 5, Enschede, route

trainers by holland innovative

Jolande Koobs
Sr. Project Manager Medical - Holland Innovative
  • Regulatory, standards, QMS  
Lisette van Steinvoren
Sr. Project Manager - Holland Innovative
  • Regulatory, standards, QMS
  • Project Management  
Theo de Goede
MBB Product & Process Professional
  • Design for Six Sigma
  • Verification and Validation based on statistics & Reliability
Ton Meek
Sr. Product & Process Specialist - Holland Innovative
  • Design for Six Sigma
  • Verification and Validation based on statistics & Reliability
Wim Schouten
Sr. Project Manager - Holland Innovative
  • Project management

registration & cancelation - this event is "sold out"

We welcome a maximum number of 12 participants. Participation is free of charge. We will count on your participation for creating working groups and catering. If you cannot attend the event for which you have already registered, we kindly ask that you let us know. Simply e-mail



This training is part of the TechMed Workshop Series ‘Remove the Barriers to Market Readiness’. This one-year-course of workshops covers the most important, but also most challenging, topics required for the development and production of a safe, reliable and useful medical device. The events are organized for (future) entrepreneurs in the medical device industry, take place every 2 months on an afternoon and focus on one specific topic every session. It is possible to attend the complete course, but also separate workshops. The TechMed Proeftuin receives funding from the European Regional Development Fund (ERDF) of the European Union; the Workshop Series can therefore be offered free of charge.  


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.