The secrets to being EU MDR certified with Shokoufeh Khodabandeh
We are talking a lot of time about how to be MDR certified and I provide you with some tips etc… In this episode of the Podcast, I wanted to interview someone that succeeded at EU MDR certification so we can get some story and secrets about what went well and what were some of the problems.
Shokoufeh Khodabandeh from Straumann in Switzerland is the EU MDR implementation lead and the team succeeded and received their EU MDR certificate. Shokoufeh will explain to us how they have done:
- How long did the project last?
- What are some of the issues that happened?
- What was the relation with the Notified Body?
- How was structured the team?
- What are some things that they would have done differently if they should restart?
This will be a really exciting episode as we get behind the curtain of a company that succeeded and they will explain how they have done it. I hope this will be helping other companies.
Who is Shokoufeh Khodabandeh?
Shokoufeh Khodabandeh is the MDR Implementation Lead at Institut Straumann AG, in Switzerland. Shokoufeh holds a Master’s of Science degree from the University of Toronto, and a Post Graduate Degree in Regulatory Affairs and Quality Assurance.
After the early career experience in IVDs and medical devices in the area of Prostate Cancer treatment in Canada, Shokoufeh moved to Switzerland as a Regulatory Affairs and Compliance Manager in the area of Dental Medical Devices, covering EU, USA, and Canadian submissions.
In her current role as the MDR Project Lead, Shokoufeh has spent the past year leading an interdepartmental project to identify the gaps in the existing QMS procedures and product documentation, and planning of the overall implementation strategy.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.
After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links from the Video
- Shokoufeh LinkedIn Profile: https://www.linkedin.com/in/skhodabandeh/
- Blog post Pitfalls on an EU MDR and IVDR project: https://easymedicaldevice.com/pitfalls-mdr-ivdr-projects/
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
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