Production of medical devices in low quantities.
Are you (intending on) running a small business in the medical devices industry? Currently struggling with the challenges of the Medical Device Directive or ISO13485 to produce small amounts of MedTech products?
During this workshop you will learn how to set up a production process for medical devices, based on your own case. You will, together with other attendees, set up the production process, with the emphasis on the requirements set by the ISO13485: 2016 and the MDD (or MDR). The teacher will give you tips and tricks for your production process. You will present your production process afterwards and we discuss the do's and don'ts together.
Note: Due to the fact you will work in a group with different attendees, only one case will be discussed per group.
During this workshop you will learn more about the background, but also about practical issues. Your own cases will be used for hands-on practice during the workshop.
Main goals are:
- Providing insights of the barriers to get to production of low quantities.
- How to set up a production process for medical devices, with the emphasis on the requirements set by the ISO13485: 2016 and the MDD (or MDR).
- Knowing which requirements needed to implement in the production process.
16:00 - 16:15
Registration and coffee
16:15 - 16:45
Introduction to medical market and ISO13485:2016
16:45 - 17:45
Workshop - Creating value stream
17:45 - 18:00
Workshop - Presenting value stream
18:00 - 18:45
18:45 - 19:30
Workshop - Questionnaire about production
19:30 - 19:45
Workshop - Answers & discussions
19:45 - 20:00
Questions, networking and drinks
If you are responsible for the development and design of a medical device and struggling with the challenges of the Medical Device Directive or ISO13485 to produce small amounts of medtech products.
- 4 December 2018
- Carré 3.022, Auditorium ECTM
- University of Twente, Drienerlolaan 5, Enschede
We welcome a maximum number of 50 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 firstname.lastname@example.org.
This workshop 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 workshops 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 Workhsop Series is part of the TechMed Proeftuin. By sharing their knowledge and expertise in the workshops series the TechMed Proeftuin partners aim to bring medical innovations 1 TRL level further and closer to a successful market introduction. 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.