Latest / Medical Device made Easy Podcast
From Zero to One: The journey of a CRO with Helene Quie
In this long-form interview, Helene Quie, founder of Qmed Consulting, shares an inside look at nearly 20 years of experience in clinical and regulatory consulting for medical devices.
This article covers:
Helene’s personal journey from employee to entrepreneur
The early risks and decisions that shaped Qmed’s growth
How the company’s services and markets evolved over time
A deep dive into clinical evidence generation vs equivalence
The seismic impact of EU MDR on clinical strategies
PMCF pitfalls and real-life examples
Working with Notified Bodies and new expectations under MDR
Lessons from…
The skinny
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