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.

Simplify technical documentation digitally and comprehensibly

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

Combined usability studies: What is it and how does it save me time and money?

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.

AI in medical devices – opportunity or risk for manufacturers

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

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