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Crashcourse MDR/IVDR

download .ICS file

Date & Time

from
Thu/Nov/202513:00 pm
until
Thu/Nov/202515:00 pm
duration
2hours

Location

Contact

Last name
Ms. Katja Krempler
leap:up GmbH
email
virtualevent

Contents: 

  • The Regulation and Basis Principles 

  • Economic Operators 

  • Annex I: Generl Safety and Performance Requirements – Selection of harmonized standards 

  • Quality Management System 

  • Annex II/III: Requirements for the content and scope of the technical documentation 

  • Clinical Evaluation 

  • Post-Market Surveillance (PMS) 

  • Medical Device Regulation and Reporting Requirements; labelling, traceability (UDI, EUDAMED) 

speaker: Dr. Katja Krempler 

costs: 50€ members, 100€ non-members