Optimizing generation of clinical evidence for medical devices - the pros and cons of trials in the 21st century

Presented by: Jon I. Bergsteinsson – CTO of MEDEI ApS

Abstract:

The updated regulatory requirements on for Medical Devices can be both troublesome and expensive. Modern MedTech organisations are looking for ways to cohere with these upgraded requirements on clinical evaluation, while also reaching the market in a timely manner.

There are regulatory, organisational, and technological factors at stake, which have to be addressed accordingly.

In this presentation, we’ll will focus on the technical and organisational aspects at play in clinical trials, and look at how Medical Device companies can reach the market faster and in compliance with regulatory requirments, by observing the pros and cons of conducting trials in the 21st century.