March 14, 2023

What you should know about Vigilance Reporting?

37 minutes

Vigilance Reporting is a process that you should have but that you don’t want to us. In fact not having any vigilance reporting is a sign that you product is doing well. But having one means that maybe you need to improve your device.

So on this episode we will explain to you what is Vigilance Reporting and how you should build it. We will explain EU reporting, UK, but also other regions. We will also mention about IMDRF guidances that are important.

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► Who is Adam Isaacs Rar?

Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.

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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:

LinkedIn profile Adam Isaacs Rae: https://www.linkedin.com/in/adam-isaacs-rae/

Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/

► Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

■ Twitter: https://twitter.com/elazzouzim

■ Pinterest: https://www.pinterest.com/easymedical...

■ Instagram: https://www.instagram.com/easymedical...

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#medtech #medicaldevice #compliance

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