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:
- Comprehend and apply the requirements of the ISO20916 as a GSP guidance specifically for IVD medical device clinical performance studies from start to finish
- Understand how risk management is applied to all aspects of IVD medical device clinical performance studies
- Comprehend the different types of clinical performance study designs and how ISO20916’s requirements apply
- Add credibility to your clinical data
- Protect your subject’s rights & safety
- Create clinical data that is accepted worldwide
- Avoid findings during inspections
- Avoid unnecessary risk for patients
- Avoid unnecessary regulatory delay
- Comply with the IVDR
- Translate the ISO20916 into your daily practice
Sign up for this training
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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
Language: the training is given in English.