Standards, Toolchains and Post-Market-Surveillance – On 21.10 the experts from BAYOOMED and HexApproach will share their expertise with you and show you what to consider when it comes to licensing and regulatory issues.
IEC 62304 – AGILITY IN THE SOFTWARE LIFE CYCLE PROCESS
4:05 P.M. – 4:20 P.M.
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 ocean of processes
4:25 P.M. – 4:40 P.M.
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
4:45 P.M. – 5:00 P.M.
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.