The ISO standard for Good Study Practice for In Vitro Diagnostic Medical Device Clinical performance studies

In this training you will get valuable, state-of-the-art information on the interpretation and implementation of the Good Study Practice in your clinical performance studies with IVD medical devices.

After this training you will be able to:

  1. Comprehend and apply the requirements of the ISO20916 as a GSP guidance specifically for IVD medical device clinical performance studies from start to finish  
  2. Understand how risk management is applied to all aspects of IVD medical device clinical performance studies
  3. Comprehend the different types of clinical performance study designs and how ISO20916’s requirements apply
  4. Add credibility to your clinical data
  5. Protect your subject’s rights & safety 
  6. Create clinical data that is accepted worldwide
  7. Avoid findings during inspections
  8. Avoid unnecessary risk for patients
  9. Avoid unnecessary regulatory delay
  10. Comply with the IVDR
  11. Translate the ISO20916 into your daily practice

Sign up for this training

By clicking on “register” below, you can see on which days this training is given.

By clicking on the available day, you can enter your details.

After receipt of payment you are registered and you will also receive the invoice immediately.

Practical information:

Time: 2-day training (with 1 day in between) from 10:00 am till 12:30 pm CET 

Target group: this training lays the foundation for manufacturers and clinical professionals who
work with In Vitro Diagnostic (IVD) medical devices


Introduction price: €247,50 (50% discount)

Normal price €495,-

Prices are excluding VAT and per participant

Number of participants: min. 3, max. 12

Certificate: certificate of participation

Location: virtual

Language: the training is given in English. 

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