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? This workshop aims to provide inside in some of the barriers to get to production of low quantities.
During the 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). You will present your production process afterwards and finally we discuss the do's and don'ts together.
After the workshop, you will have knowledge of the requirements needed to implement in your production process. Tips and tricks have also been given for your production process.
Note: Due to the fact you will work in a group with different attendees, only one case will be discussed per group.
15:15-16:00 Presentation (depending on the number of participants)
16:00-16.15 Questions & Wrap up
If you are responsible for the development and design of a medical device a struggling with the challenges of the Medical Device Directive or ISO13485 to produce small amounts of medtech products.
24 April 2018, 13.00-16.00 hrs
University of Twente, building Carré, CR 3022
Register before 20 April 2018, 12:00. We will welcome a maximum number of 50 participants, participation is free of charge.
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.