Session 1

  • Introduction to IVD-R
  • Classification
  • Conformity Assessment
  • PRRC
  • Labelling & UDI
  • Risk Management

Session 2

  • Clinical Evidence
  • Performance Evaluation Plan/Report
  • Scientific Validity 
  • Analytical & Clinical Performance
  • Design Control 
  • State-of-the-art

Session 3

  • Post Market Surveillance
  • PMS Report
  • Periodic Safety Update Report
  • Post Market Performance Follow-up
  • Economic Operators
  • Supplier Management



These online courses are offered as separate clusters at different times. Each of the clusters contain all three sessions described above.

Please chose either of the clusters at the time that suits you best:

  • July 6, 7 and 8 between 2 pm - 6 pm (CEST)
  • August 31, September 1 and 2 between 9 am - 1 pm (CEST) 
  • July 26, 27 and 28 between 4 pm - 8 pm (CEST)
  • September 6, 7 and 8 between 4 pm - 8 pm (CEST)

All sessions are sold out!



Maurizio Suppo, Ph.D.

Vice-President and co-owner
Principal Consultant



Customer's past experience:

Dear Maurizio,

Thank you very much for your outstanding presentation of the PRRC role. 
I feel much more prepared; and, really enjoyed your examples. 
Thank you also for providing the slide decks.  I will use these as great reference materials as we enter the IVD-R world.

Dan Kiser - Vice President, Quality, Regulatory at ProciseDx, Inc.



You can enjoy the entire PRRC training for a fixed fee of €2000*/participant. 

* Price excl. VAT


This course is specifically aimed to create a very interactive environment which enables interactivity, Q&A sessions and sharing of mutual experiences, problems commonly encountered and lessons learned.

To allow this high level of interaction, there is a limited seating of minimum 4 and maximum 10 participants.

Training certificates

At the end of this course, you will receive an effectiveness test of 30 questions. If you pass the test, you will receive a training certificate.



ISO Certified
ISO 13485 and ISO 27001


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