Workshop: How to write your Intended Purpose? [Medical Device case study]
Easy Medical Device
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Workshop: How to write your Intended Purpose? [Medical Device case study]
4 110 просмотров · 6 л. назад
Easy Medical Device
15,6 тыс. подписчиков
4 110 просмотров · 6 л. назад
During this LinkedIn Live, we have started to explain the concept of Intended purpose and then used 2 examples to show you how to create that.
This is in line with the EU MDD 93/42/EC and the EU MDR 2017/745. You can download from below the DOWNLOAD PACK with:
The pdf showing the different steps
The example for the Medical Device Application
The example of the Wound healing laser
The Mindmaps were created with Mindmanager. You don't need the software to see the files. I created some files that you can view without.
If you have any other questions don't hesitate to contact us.
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► Who is Cesare Magri?
Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. Recently he founded be-on-Clinical together with Stefan Bolleininger in 2020.
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► 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...
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► Links from the Video
■ Download Pack: https://mailchi.mp/easymedicaldevice/...
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#eumdr #medicaldevice #regulatoryaffairs