Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie

How to define Product Equivalence on your CER or Clinical Evaluation Report with Helene Quie on the Medical Device made Easy Podcast - Monir El Azzouzi

If you are really confused about Product Equivalence for your Clinical Evaluation Report or CER, then you are at the right place. Just hit the play button as Helene Quie from Qmed Consulting will be providing you some great information.

On this episode of the Medical Device made Easy Podcast, we will go through some specific aspect of Product Equivalence as:

  • Clinical Equivalence
  • Biological Equivalence
  • Technical Equivalence

This master class regarding Clinical Evaluation Report (CER) will help you be compliant for the new Medical Device Regulation EU MDR 2017/745. The mindset of Notified Bodies changes so they will be stricter regarding clinical aspects to prove the safety of your product.

Who is Helene Quie?

Helene Quie has a degree in Science specialized within cell biology from the University of Odense. Helene has 20 years of experience within the pharma and medical device industries working for inter alia Cook Medical A/S, H. Lundbeck A/S, AMBU A/S and Millimed A/S.

Her primary expertise is within the clinical and regulatory areas such as device development, quality management, project management, clinical trial execution, market access, and general management.

In 2006 she founded Qmed Consulting as a private consultancy company providing services within medical device development and clinical trials.

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2 Replies to “Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie”

  1. Vijay Arora

    Indeed surprising to note that there is not much of a change from the meddev, rev.4 of 2016 on CER.
    But yes interpretation of a standard changes with the passage of time and deeper understanding of the subject.
    So a better understanding of the CER concept and hence better implementation at the advent of MDR 2017/745, with stricter compliances. Notified Bodies and Clients….. Bigger Challenge to accomplish.
    Thank You.

    • Monir El Azzouzi

      Thanks Vijay for this comment. It is clear that the new regulation is maybe not revolutionizing the requirements but strengthening the scrutiny of Notified Bodies. So something to take into account.

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