Create your intended purpose with Cesare Magri (Medical Device)
As Cesare Magri said, the intended purpose is not really a priority for some companies so they don’t take to much time to write them. But you will hear in this episode why it is clearly a strategic task for your company.
When you are creating your EU MDR 2017/745 technical documentation, you have to also define some scope for your product. And it is the objective of the intended purpose.
Cesare Magri from be-on-Clinical (which is related to be-on-Quality) is helping companies and he sees a lot of examples of issues related to the intended purpose. He will share with us the different steps needed to build your intended purpose and he will offer also a document to download that can be used to brainstorm regarding your intended purpose with your team.
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.
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
- Cesare Magri LinkedIn: https://www.linkedin.com/in/cesare-magri-92465345/
- Download Presentation: https://mailchi.mp/easymedicaldevice/intended_purpose
- Check the Easy Medical Device Shop: https://school.easymedicaldevice.com/shop/
- Episode 40 – How to perform Product Equivalence on your CER?: https://podcast.easymedicaldevice.com/40/
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