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.
Especially for small and innovative businesses, it is a challenge to comply with regulations and prepare your business plan upfront. In this workshop, you get the opportunity to discuss your case and ask the experts! After a short and solid background talk, the experts from Unitron Group bv will address the challenges that innovative or small companies have to deal with by means of some cases. You can also introduce your own case and we will discuss the available routes in small number production.
13.15-13.45 Business aspects
13.45-14.30 Demands concerning production with respect to ISO13485
14:30-16:00 Discuss your case - or case examples
16:00-16.15 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.