#read

Workshop: Crash course MDR/IVDR

Date & Time

from
27/11/202513:00 pm
until
27/11/202515:00 pm
duration
2hours

Location

city
Online

Contact

Last name
Dr. Katja Krempler
leap:up GmbH
phone
+49 162 6053-598
email
virtualevent

Content:

  • The regulation and the basic principles
  • Economic operators
  • Annex I: General safety and performance requirements - Selection of harmonised standards
  • Quality management system
  • Annex II/III: Requirements for the content and scope of technical documentation
  • Clinical evaluation
  • Post-market surveillance (PMS)
  • Medical Device Regulation and reporting obligations; labelling, traceability (UDI, EUDAMED)

Short biography of the speaker:

Katja Krempler holds a doctorate in biology and has many years of experience in quality management, regulatory affairs and the authorisation of medical devices. After working as a regulatory manager and QMB in a Leipzig start-up, she has been supporting start-ups and SMEs in the areas of quality management systems, technical documentation and regulatory issues at leap:up since 2024.

Costs:

  • €50 for biosaxony members
  • €100 for non-members

The workshop will be held in English.

Register now and send an email to katja.krempler@leap-up.com!

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