BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//YourOrganization//EventDownload//DE
CALSCALE:GREGORIAN
METHOD:PUBLISH
BEGIN:VEVENT
UID:69e509eadfb83@leapup.bitshifters.cloud
DTSTAMP:20260419T185922Z
DTSTART:20250702T085500Z
DTEND:20250702T151500Z
SUMMARY:Approval of software as medical device in Europe: Overview of the requirements and insights from practice (Online)
DESCRIPTION:Manufacturers of software with a medical intended purpose are subject to many laws and other regulations in Europe. These are primarily the Medical Device Regulation (MDR) and the In-vitro Diagnostic Medical Devices Regulation (IVDR). Manufacturers must also comply with the relevant guidelines and technical standards. In addition\, there are requirements from horizontal EU legislation such as the Artificial Intelligence Act (AIA) or the existing General Data Protection Regulation (GDPR) as well as from national legislation such as the Medical Devices Implementation Act (MPDG) in Germany.\nIn this event\, you will receive an overview of the requirements to be complied with from relevant laws\, standards and directives. The theoretical basics will be supplemented by practical examples from the professional activities of the expert Dr Thorsten Prinz (VDE). The event format offers sufficient time for your questions and discussions.\nThe presentations will be given in German. You will receive all presentation files as PDF (in English). As a special bonus\, all participants of this event will receive a list of the requirements for medical devices as high-risk AI systems in accordance with the provisions of the Artificial Intelligence Act in PDF format.\nWe are looking forward to your participation!\nMore
END:VEVENT
END:VCALENDAR