What you should know about Vigilance Reporting for Medical Devices?
Medical Device made Easy Podcast
English - March 14, 2023 00:00 - 52 MB - ★★★★★ - 18 ratingsCareers Business Education Courses medical device regulation medtech industry regulatory affairs iso mdr 2017/745 Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
Vigilance Reporting is one of the process that everyone should have but that no one wants to use. So this is really difficult to understand all the requirements to it. Also knowing that this may change from one coutry to another.
The post What you should know about Vigilance Reporting for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir
Vigilance Reporting is a process you should have but don’t want to use. In fact not having any vigilance reporting is a sign that your product is doing well. But having one means that maybe you need to improve your device.
So in this episode, we will explain to you what is Vigilance Reporting and how you should build it. We will explain EU reporting, the UK, but also other regions. We will also mention IMDRF guidances that are important.
Who is Adam Isaacs Rae?
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.
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.
Links
Article for Vigilance to download: https://podcast.easymedicaldevice.com/wp-content/uploads/2023/03/Vigilance_Reporting_The_Other_Consultants__Easy_Medical_Device_.pdf
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…
The post What you should know about Vigilance Reporting for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir