Approval and regulatory

Watch the recording of the first lecture in our series “Digital instead of analog” now


On October 21, the third block of our lecture series “Digital instead of analog” took place. The event revolves around the topics of authorization and regulatory issues (e.g. post market surveillance). Among other things, the speakers clarified what has changed with regard to market surveillance since the introduction of the new MDR. How you can update your technical documentation in this respect and which tool support will help you.

IEC 62304 thought agile: How to use the standard to your advantage

Speaker: Miriam Schulze, Director Medical Engineering at BAYOOMED

IEC 62304 anchors regulatory requirements for the development of medical software. Agile software development seems to contradict the normative requirements. But only at first glance. How can you use the standard in an agile way? Miriam Schulze will show you practical solutions in this presentation.

Post Market Surveillance – definitely not an island in the process ocean

Speaker: Peter Wellmann, Medical Consultant HEXApproach

With the introduction of the MDR, the requirements for post market surveillance have been regulated even more strongly. Market surveillance results have consequences. We show you how you can counter this to update your (technical) documentation.

Tool-supported assurance of traceability according to IEC 62304 in the context of risk management

Speaker: Thorsten Berndt, Product Owner at BAYOOSOFT

How can compliance with traceability requirements according to IEC 62304 be ensured across tool boundaries, in particular with regard to the connection with risk management? We show you a practical solution path with the help of BAYOOSOFT Risk Manager.