Technical Files Inconsistencies Identified by Notified Bodies
Medical Device made Easy Podcast
English - May 16, 2023 00:00 - 33.1 MB - ★★★★★ - 17 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
Technical Files inconsistency, it is when your technical file is not providing the right information or that all the information is not aligned. Here we will try to look at some of these issues.
The post Technical Files Inconsistencies Identified by Notified Bodies appeared first on Medical Device made Easy Podcast. hamza benafqir
This week with Adam Rae we will talk about the Technical Files inconsistency that we noticed while working on some projects. Adam will provide his list of issues like Intended purpose, Clinical Evaluation… So if you want to avoid these issues don’t miss this episode as they can cost you time and money.
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 in 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
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 Technical Files Inconsistencies Identified by Notified Bodies appeared first on Medical Device made Easy Podcast. hamza benafqir