Medical Devices – MDR

A summary of all MDR seminars – keeping your employees fully up to date!

• General safety and performance requirements for active medical devices (incl. software)

• Requirements & processes for the development of medical devices and IVDs

• Basic course ISO 13485:2016 – Quality management for medical devices & IVDs

• basic course MDR

• ISO 10993 – Biocompatibility of medical devices

• ISO 14971:2019 – Risk management for medical devices & IVDs

• Clinical Investigation and Evaluation of Medical Devices according to the MDR

• Labelling and Unique Device Identification (UDI)

• MDR or IVDR gap analysis

• Technical documentation for MP & IVD according to MDR / IVDR

• Post-market surveillance: Post Market Surveillance