At this event, Christian Johner and Andrea Seeck from the Johner Institute and Sven Wittorf from Medsoto GmbH will address the digital red thread in quality and regulatory affairs management for manufacturers of medical technology and products.
The focus is on the continuous data flow and the consistency and traceability of information and documents. Christian Johner opens the event with the contribution “Digitalisation and monitoring of standards” from the Johner Institute. Andrea Seeck picks up the thread and shows how the automated monitoring of regulations helps to ensure compliant products and processes. Sven Wittorf links this digital QM/RA thread with practical experience from R&D in his contribution “Integrating regulatory requirements into the development process”.
Finally, there will be enough time for questions.
15:00 – 15:15: Welcome address 15:15 – 15:45: Impulse Talk “Digital transformation of regulatory processes” — Prof. Dr. Johner 15:45 – 16:15: Industry Talk “Automated monitoring of regulations ensure compliant products and processes” — Dr. Andrea Seeck, Johner Institute 16:15 – 16:45: TechTalk “Integrating regulatory requirements into the development process” — Sven Wittorf, Medsoto GmbH 16:45 – 17:00: Discussion & Questions