Product Equivalence for Clinical Evaluation Report (CER) with Helene Quie
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.
Links
- Qmed Consulting: https://www.qmed-consulting.com
- Qmed Podcast: https://www.qmed-consulting.com/podcasts.html
- MEDDEV 2.7/1 rev 4: https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/en/renditions/native
- TOPRA symposium 2019 – October 1st and 2nd 2019: https://www.topra.org/TOPRA/TOPRA_Member/Symposium_2019/TOPRA_Annual_Symposium.aspx
- TCT – September 25th to 28th – San Fransisco – USA https://www.crf.org/tct
- OCT – October 22-23 – Copenhagen – Denmark https://www.arena-international.com/octnordics/
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