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Bernhard led Swissmedic’s Medical Device Department during the past 7 years and was a member of various European Working groups. Among others, he was a very active member of the CAMD Executive Group (https://www.camd-europe.eu), where he was heavily involved in MDR/IVDR implementation activities.

Originally, he started-off as an Electrical Engineer, focused on production, verification and validation, component testing, quality systems and supplier audits. On top, he holds an Executive MBA in General Management from the University of St. Gallen.

At ISS Bernhard will act as strategic business developer and senior consultant, and he will be a member of the executive board.

Due to the present context (COVID-19), we slightly adapted the program of our Medtech Bootcamp. We decided that the lectures will be held remotely (webinar) from today on.

Only the crews who remain welded and join forces can keep the boat floating and maintain the right heading…

20200316 MedTech Bootcamp Week 3 Infomation

 

A big thank you to Thomas Bohnen, CEO Qualitätsplan Lübeck, DE for the interesting speech yesterday evening about how 60601-1 tests are set up in practice.

More about our evening program:
https://www.iss-ag.ch/bootcamp-event-program
If you would like to participate, please send us an e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

20200310 MedTech Bootcamp Speech   Thomas Bohnen

It was very interesting to have Andreas Baier, Director & Principal of Ergonomics Factory GmbH as our guest speaker.

More about our evening program:
https://www.iss-ag.ch/de/bootcamp-event-program
If you would like to participate, please send us an e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

20200310 MedTech Bootcamp Speech   Andreas Baier

On Thursday, 19 March 2020 (10:15 am – 12:00 am), Hansjörg Riedwyl, CEO of Integrated Scientific Services in Biel and expert in business development, will give a guest lecture at the ETH Zurich (Maschinenlaboratorium, Sonneggstrasse 3, Room ML H 37.1).

The lecture is about Apps and Medical Device Software. Digital health interventions offer a lot of new opportunities for all involved, not only for patients, but also for healthy individuals as well as physicians. However, there is to be considered that digital health interventions can become medical devices according to medical device regulations (MDR) and these regulations are dramatically changing. Therefore, it is crucial for managers and developers to understand the borderline between a “normal” software application and Software Medical Device Software (MDSW).

More information on the following link.