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 projects that didn’t go as planned
• The crucial alignment between clinical data and human factors
• Practical advice for startups on avoiding top regulatory mistakes
• Her vision of the future: RWE, adaptive study designs, digital health & greater regulatory convergence

Links:

Helene Quie: https://www.linkedin.com/in/helene-quie-863a323/

Qmed Consulting: https://qmed-consulting.com/

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice