Overcome the 3 most Common Pitfalls in Medical Device Clinical Studies
To maximise resources and overcome new challenges brought on by the new MDR and IVDR requirements, clinical teams need to eliminate typical issues that can hinder a successful transition towards compliance.
As a service provider for MedTech clinical teams, there are several pitfalls we've observed repeatedly in both pre- and post-market clinical investigations. In this session, Jón will share insights and experience on these common pitfalls and provide advice on how to mitigate and prevent them. In his talk he will share insights on:
- Why is it important to get the sample size right,
and how do you do it?
- Myths about GDPR. Are you missing out on
- PMCF Studies. How do you ensure that you
get the data you need?
Keywords: Common Pitfalls, Medical Device, Mitigate and Prevent
Jón I. Bergsteinsson
Brought to you by SMART-TRIAL