Achieving more "speed" in "time to market" with digital regulation.
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.
Please note: This lecture will be held in German.
Supported by: Medtech Cluster Alliance D-A-CH