Webinar: Get a new approach on obtaining a CE mark
Understand the critical CE certification hurdles.
Address how an outsourcing model impacts development, production and distribution.
Discuss regulatory challenges for innovative small companies.
CE certification is mission critical and creates incalculable risks especially for small and middle-size mHealth companies. Regulatory issues may not be their primary focus and competence. And the hurdles of market access become higher: In May 2020 the new medical device regulation (MDR) will come into force. Certain products will be up-classified – particularly «Software as a Medical Device» of the current class I. Thus, industry experts call for new approaches to counter increasing regulation. One of them is to outsource the CE certification. Instead of doing the time and cost-intensive CE certification process on their own, a professional legal manufacturer takes on.
Beni Hirt is co-founder and CEO of Decomplix – a platform that simplifies market access for medical and in vitro diagnostic devices. He co-founded and ran one of the most successful Swiss app agencies. Beni is a Business Administrator experienced in the mobile app and medical device industry. As strategist and project manager he knows the different perspectives of start-up’s, corporates and SMEs.
Josef Neubauer is quality and account manager with a background of biomedical engineering. Joining Decomplix 2016 as a consultant he built up essential parts of the ISO 13485-certified QMS. Already during his studies, he focused on software as well as app development and is now the CEO of a start-up in Austria.
Register and join us online on 8-June-2018, 11 am CEST. After registration, you will receive a link via email to join the webinar. There will also be a live chat for Q&A at the conclusion of the presentation.