BHH members ERNI and Asphalion teamed up to organize a webinar about The Journey from “Software” to “Medical Device” on Tuesday June 8 at 9:30 am CET. Do you know if your software product acts as a Medical Device? Are you interested on what aspects are needed so your software product becomes regulatory compliant with the Software as a Medical Device regulation in the EU? Are you interested on learning how technology and best practices can boost the design, release, maintenance and CE certification of your product? Discover it all in the webinar!
They will go through different use cases to understand how the new EU regulation impacts on existing or new software products. They will see how a software product is classified in terms of software risk class, as a medical device software or as a in vitro diagnostic software. They will also review how you can embrace edge technologies (data) and fulfill a CE-compliant product development process under the new regulation (Medical Device Regulation – EU/2017/745 or In Vitro Diagnostic Medical Device Regulation – EU/2017/746).