New EU MDR/IVDR Regulation – Solutions for SME

The new MDR/IVDR regulations present the entire medtech industry with a major operational and strategic challenge, the effects of which will severely impact the business performance of many companies, especially SMEs. Event language is German.

All companies are faced with a great challenge. The first companies are preparing GAP analyses to help them implement the strict implementation requirements by 2020 (MDR) and 2023 (IVDR).

At present there are many unanswered questions, especially as the interpretations of the laws have not yet been established. The situation is aggravated by the fact that in Switzerland there is a shortage of qualified labour (estimated 1400 specialists) on the one hand, and a shortage in the operating budget of Swiss companies (up to CHF 400 million per year) on the other.

This event brings together leading experts from industry and the service sector to get to the bottom of the current situation and discuss possible ways out of the various dilemmas. On the basis of facts, practical examples and inspiring concepts, the event offers a platform with presentations and a panel discussion to exchange ideas for practical solutions and concrete measures.

The event is aimed at decision-makers from the field of medical technology. The event will be held in German.





Arrival of guests



Welcoming speech

Stefan Leuthold, Health Tech Cluster Switzerland
Danielle Spichiger, Business and Economic Development Division, Office for Economy and Labour, Canton of Zurich



Relevant changes and what to keep in mind

Hansjörg Riedwyl, ISS AG, Integrated Scientific Services



Challenges and economic consequences of MDR and IVDR

Beatus Hofrichter, ConCeplus GmbH



Field report - New ways for SMEs and start-ups in the implementation of MDR and IVDR

Beni Hirt, Decomplix AG



Field report - Perspective of an SME

Simon Ackermann, VOSTRA-MED AG



Panel discussion


Simon Ackermann, VOSTRA-MED AG
Nicolas Bouduban, 41medical AG
Karina Candrian, Effectum Medical AG
Beatus Hofrichter, ConCeplus GmbH
Hansjörg Riedwyl, ISS AG



Stefan Leuthold, Health Tech Cluster Switzerland



Apéro and networking



End of the event



The event "Health Tech Regulation" will take place within the framework of IFAS 2018. Therefore you need a trade fair ticket for admission. You can obtain it here free of charge: https://ticket.messe-tickets.ch/MCH/IFA2018/Register/HEALTHTECHCLUSTER18


Please register by 18 October 2018.
Your registration is binding.
Participation is free of charge.


The registration is only available in German.