There are many tasks in Regulatory Affairs: The main objective of obtaining market approval for a medical device is affected by important regulations that must be complied with and kept up to date at all times.
To keep your employees up to date, we recommend the following seminar topics:
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General safety and performance requirements for active medical devices (incl. software)
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General safety and performance requirements for in-vitro diagnostics
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Internal audits according to ISO 13485
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ISO 10993 – Biocompatibility of medical devices
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ISO 14971:2019 – Risk management for medical devices & IVDs
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Labeling & UDI marking
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Technical documentation for MP & IVD according to MDR / IVDR
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UX and usability for medical software and apps
