Navigating Compliance with AI Act for Medical Devices

I am an EU pharma/device lawyer and problem solver.
My practice focuses on European Union (EU) and national regulatory matters involving medical devices and pharmaceutical laws and guidelines. I am following very closely the new regulations on medical devices (MDR and IVDR), the GDPR and regularly advise clients in relation to the requirements applicable to their digital health technologies.
I focus particularly on the different stages of the medical device CE marking process and advise on a wide variety of topics which include the following:
- determination of the appropriate classification of individual products;
- clinical investigation procedure (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data);
- drafting of clinical investigation and clinical trial agreements, distribution agreements and contract manufacturing agreements;
-clinical data requirements and clinical evaluation;
- conformity assessment procedure;
- review of Instruction For Use, products' labelling and promotional material including websites;
- post-marketing surveillance activities including the notification of adverse event, product recall or product withdrawal;
- preparation and review of technical documentation;
- reimbursement.
I also advise on questions regarding marketing authorisation procedures, variation procedures, and clinical trials, promotional and marketing activities in the pharmaceutical sector.
Specialties: Regulation of medical devices and medicinal products in the EU
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
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► Links from the Video
Fabien Roy Linkedin Profile: / fabien-roy-83b55021
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#easymedicaldevice #medicaldevice #regulatorycompliance

[@EasyMedicalDevice]

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