How to conduct Clinical Investigation competent authority submission in Denmark

With clinical specialist and entrepreneur, Helene Quie




What is this class about?

The course will cover the process including:
·      Which documents to prepare before submission?
·      Available tools to prepare the submission – review of available guidelines and regulation.
·      How to create a submission that will give a potential fast review and approval time – tips and tricks?
This class will be hosted on Team and the link will be emailed to you after your registration and payment.

Why should I attend?

This workshop is designed for submission responsible or clinical specialist, entrepreneurs, study nurses or PhD students. If you need to submit a medical device clinical investigation (clinical study) to the competent authority and you’re not exactly sure how and where to start, Helene Quie will guide you through a series of processes to help you put a complete submission package together and obtain a high success rate in have a fast approval.




This Lecture will be held on
Tuesday, 26th January at 3:00 PM CET
Tuesday, 9th February at 4:00 PM CET
Tuesday, 23rd March at 2:30 PM CET



Course Curriculum

  Lecture 2
Available in days
days after you enroll

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.

Select a pricing plan and sign up

€95

Lecture 2

Medical device clinical trial competent authority submission - Denmark

Who this is for:

Company submission responsible or clinical specialist, entrepreneurs, study nurses or phD students.


Want to know how to put together a submission package together to the Competent Authorities in Denmark? Start here and discover the process!