11.01.2022 - By easymedicaldevice
This month we will have some updates on:
Annex XVI
ACRAS Event
MDCG Agenda
Commission Contact update
Team-NB position paper on Off-label use
Team-NB position paper on Cybersecurity
New Notified Body for EU MDR
Notified Body survey
MHRA 12-month extension
MHRA’s new Vigilance system
Swiss Medtech proposal
Team-PRRC annual meeting
USA Medsun
Malaysia training on Good Distribution Practices
China Medical Device Recall
EU MDR training
EUDAMED training
PRRC Training
Book to buy
Podcast episodes of the month.
Enjoy!
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
Links to the episode: https://www.medboard.com/reports/easymedicaldevice/regulatory-update/