Crash course in how to conduct a clinical evaluation according to MDR
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With clinical specialist and entrepreneur, Helene Quie
What is this class about?
Interested in learning the overall processes in conducting a clinical evaluation; -understand the requirement, the different stages and what other processes are connected to the clinical evaluation process.
This class will be hosted on Team and the link will be emailed to you after your registration and payment.
Why should I attend?
Do you want to understand the basics behind how to set-up and write a clinical evaluation? We will talk about:
· The general regulation
· What is clinical evidence
· Clinical evaluation plan and report set up and structure according to MDR and MEDDEV 2.7/1 rev.4 Clinical evaluation: Guide for manufacturers and notified bodies
· Principal of equivalence (MDR)
· Post market clinical follow-up PMCF)
· Lifecycle of the Clinical Evaluation Report (CER)
· Tips and tricks on what Notified Body is looking for!
The Lecture will be held on
Thursday, 4th March at 4:00 PM CET
Course Curriculum
Hi, I’m Helene Quie
Co-founder of Qmed Academy and senior advisor. I have 25 years of experience in the medical device industry, supporting companies from start-up to well established companies.