How to perform a Clinical Investigation for your Medical Devices?

Clinical Investigation is one of the toughest processes within the EU MDR 2017/745. If you have to perform one for your Medical Devices then it can be a long and expensive process.
In this episode, Helene Quie from Qmed Consulting, will help us understand how to perform it in a good way. This episode will answer some of the questions you have about Clinical Investigation and we hope this will make more clarity for you.
Some of the questions answered are:
■ Which products do need a clinical investigation?
■ Can we test our products on our employees without a clinical investigation?
■ How long does it take and how much does it cost?
Don’t hesitate to go below check the links on the different guidance.
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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 a 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, podcasts, Online courses...
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► Links from the Video
■ Helene Quie Linkedin Profile: / helene-quie-863a323
■ Qmed Consulting: www.qmed-consulting.com/
■ MDCG 2021-8. ec.europa.eu/health/sites/def...
■ MDCG 2021-6: ec.europa.eu/health/sites/def...
■ MDCG 2020-10: ec.europa.eu/health/sites/def...
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#EasyMedicalDevice #medicaldevices #regulatorycompliance

[@forkedtongue7]

Very insightful conversation. Thank you Monir and Helene.

[@Han-dle598]

Thanks for the discussion, especially the points about recommended sample size in various situations

[@DrSwati7]

I want to know is there any application or software by which this clinical investigation is done easily

[@EasyMedicalDevice]

We have made some videos abour software like smart-trial or climedo