Program

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
 

Practical

When

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

Trainer

 

Maurizio Suppo, Ph.D.

Vice-President and co-owner
Principal Consultant

 

 

Price

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

* Price excl. VAT

Participants

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.

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