Jon I. Bergsteinsson on MDR: Separating the data haves from the have-nots
Send us Fan Mail
Imagine if all pharmaceutical companies had to re-apply for approval of all existing drugs. Crazy as it seems, this is what is happening in the medical devices space.
Ivanna and Sam speak to Jon I Bergsteinsson, founder of Smart-Trial by Greenlight Guru. We speak about the state of clinical trials in medical devices - and the increased diligence required by the med MDR regulation by EMA.
One of the ways medical devices differ from drugs is that it is mostly physicians and clinicians who have been interested in expanding their use for novel applications - and could do that…
The skinny
The skinny isn't ready yet — notes appear once the transcript is processed.