•Team-NB Sector Survey 2022 :[ Ссылка ]

• MDCG planning available :[ Ссылка ]
•TEAM-NB position paper : [ Ссылка ]
•Finland - Electronic Submission for Medical Devices :[ Ссылка ]

•France- Digital Medical Application reimbursement :[ Ссылка ]
• Switzerland - IVD performance studies : [ Ссылка ]
•Switzerland – IMDRF OFFICIAL OBSERVER :[ Ссылка ]
• UK - Transition from CE to UKCA :[ Ссылка ]
• Training EU MDR :[ Ссылка ]
oTitle: USA: Draft guidance on PCCP for AI/ML :[ Ссылка ]
o USA: Radiation Sterilization Master File Pilot Program :[ Ссылка ].
o Australia: Regulation for software based medical devices :[ Ссылка ]
o China: Guideline for Medical Device :[ Ссылка ]
o India: List of Notified Bodies registered in India :
o Mexico, Colombia & Cuba sign the Acapulco Declaration : [ Ссылка ]
oSaudi Arabia Webinars :
•May 9, 2023 Guidance on Medical Devices Classification [ Ссылка ]
•May 22, 2023 Product Sterilization Requirements for Medical Devices [ Ссылка ]
oPodcast Nostalgia
•Episode 227: What is a SOUP for your Software Development Christian Kaestner Medical Device HQ [ Ссылка ]
•Episode 228: Prepare your Audit like a PRO with Karandeep Badwal [ Ссылка ]
•Episode 229: Transition to Agile for Software as Medical Device: [ Ссылка ]

Ask Easy Medical Device . We can help you
•Contact at info@easymedicaldevice.com

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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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■ Monir El Azzouzi Linkedin: [ Ссылка ]
■ Twitter: [ Ссылка ]
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■ Instagram: [ Ссылка ]
■ Authorized Representative and Importer services:[ Ссылка ]
■ Subscribe to our LinkedIn Newsletter: [ Ссылка ]

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