"Speed up time to market" - digitalisation and AI for a faster and safer regulatory process

The MDR and IVDR bring new regulatory requirements. Among other things, the creation of documentation, the communication channels in the authorisation process and also the inspections have become much more complex. Digital document management and approval systems are often already in use. Initial steps have been taken with shared digital data rooms with some notified bodies. But how can an end-to-end digital process and digital creation and preliminary review of documentation be implemented with the aim of realising secure but also fast regulatory processes? This question, the current status of digital processes and solutions will be highlighted in the session and discussed with experts.

15:00-15:05       
Welcome and presentation of the DACH Medtech Alliance (Frauke Wurmböck)

15:05-15:20       
The timeline of a certification process under MDR (Harald Rentschler)

15:20-15:35       
Opportunities and risks of digital product file review and automated processes (Alexander Fink)

15:35-15:45       
Digitalization and AI solutions in the regulatory process (Michael M. Kania)  

15:45-15:55       
Perspectives of digitalization and AI in the regulatory process at the Notified Body 
(Dr. Andreas Purde)

15:55-16:05       
The digital transformation of the medical device ecosystem - a field report
(Prof. Dr. Christian Johner)

16:05-16:30       
Panel discussion: Between wishful thinking and reality - which solutions will help the industry?
(Moderation: Dr. Claudia Luther und Dr. Frank Miermeister; Panelists: Harald Renschler, Alexander Fink, Michael M. Kania, Dr. Andreas Purde, Prof. Dr. Christian Johner)

Please note: This lectures will be held in German. The lectures will be translated into English via voice-to-text so that you can follow the lecture live in written form via a monitor.

Supported by: Medtech Cluster Alliance D-A-CH