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ISO20916:2019

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

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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.

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”This training was very useful with an in-depth review and analysis of ISO20916:2019.“
Anonymous trainee - In-company training
”This training was very well structured and in-depth."
Anonymous trainee - In-company training
”Rianne encouraged the interaction by which the training was easy to follow and contributed to my knowledge and skills.“
Anonymous trainee - In-company training
"I found the quizzes and Q&A discussions in between very useful and valuable.“
Anonymous trainee - In-company training
"I would definitely recommend this training to my colleagues and other interested parties.“
Anonymous trainee - In-company training
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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

Price:

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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