Our focus on 23.09 is entirely on product development. Of course, risk management will not be missing. But also knowledge about usability studies and the approval of medical devices will be brought closer to you in the first block of the lecture series.
16:05 – 16:20 Uhr
In this presentation, you will learn how to document the interlocking of risk management and usability with digital tools in a comprehensible way, how to present the application specifications in a comprehensive and transparent way, and how to record the results of the formative and summative evaluation in a clear and detailed way.
Christine Erb
Medical Consultant and Solution Representative at BAYOOSOFT
Dr. Michaela Kauer-Franz
Medical-Expertin and CEO at Custom Medical
16:25 – 16:40 Uhr
What are combination studies? And in which cases are they used? In this presentation, medical expert Dr. Michaela Kauer-Franz will show you what to look out for in combined usability studies and how you can use digitization to save time and money.
16:45 – 17:00 Uhr
The possible application scenarios of artificial intelligence in medical technology seem endless. But what is there to consider in the development for approval of such products? This presentation provides an overview of the regulatory requirements in the EU and the US.
Alfred Koch
Legal Counsel / Regulatory Affairs at BAYOOMED
Svenja Winkler
CEO
[email protected]
Franziska Weiß
Head of Sales
[email protected]
