This podcast episode is following a presentation I have made during the Greenlight Guru Summit on EU MDR and IVDR.
I have explained how to create a label that fulfills the requirements of the EU MDR. I have placed on the show notes the link to it.
After the session, I have received a lot of questions and I didn't have the time to answer all of them, so I said to myself that maybe it would be better to have 1 podcast episode instead of me answer per email to each person.
I am sure that the question people asked is common to other persons so let's review that together.
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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 companies 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
■ Medtech Europe: [ Ссылка ]
■ BSI Presentation: [ Ссылка ]
■ Greenlight Guru presentation: [ Ссылка ]
■ The overriding ISO site for a login search: ISO -[ Ссылка ]
■ The MDCG - Landing page on Guidance documentation: [ Ссылка ]
■ The EU Fact Sheet Landing page: [ Ссылка ]
■ The Online Browsing Platform for symbol search: [ Ссылка ]
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► Social Media to follow
■ Monir El Azzouzi Linkedin: [ Ссылка ]
■ Twitter: [ Ссылка ]
■ Pinterest: [ Ссылка ]
■ Instagram: [ Ссылка ]
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#medicaldevices #easymedicaldevice #regulatorycompliance
How to create a Label under EU MDR (Questions & Answers)
Теги
medical devicesmedtech industrymedical device regulationregulatory affairs medical devicesmedical device trainingGreenlight guru summitEasy Medical DeviceMonir El AzzouziHow to create label under EU MDR 2017/745Label requirements under EU MDREU MDR annex I label requirementsLabel requirements for Medical DevicesLabel and IFU for medical devicesUDI on the label for medical devicesMedical Device labeling requirementsMedical Device packaging