Regulatory Update Monthly Podcast

November 2022 Podcast Episode

Easy Medical Device and MedBoard collaborate to bring you the Top MedTech Regulatory News of the Month.

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Podcast Footnotes by MedBoard:

European Union Guidance October 2022 Implementation Rolling Plan Vote
ACRAS Event ACRAS Event
European Union Meeting MDCG agenda - October 24th
European Union Guidance Team-NB position paper for data generated off-label use
European Union Guidance Team NB position paper on Cybersecurity Use of IEC 81001-5-1 Health Software Security IEC TR 60601-4-5 Safety related technical security specification
European Union Notice EU MDR Notified Body ECM Italy
European Union Report Notified Body Survey on application
United Kingdom (UK) Notice MHRA extension of 12 months for the implementation of the future regulation
United Kingdom (UK) Guidance MHRA Vigilance Reporting system update
European Union Event Team PRRC annual summit in BRUSSEL November 3-4 2022
European Union Notice Commission updated the contact page for DG SANTE
REST OF THE WORLD
United States of America (USA) Report USA - Medsun October 2022
Malaysia Event Malaysia Training on GDP for Lead Auditors
China Regulation China Medical Device Recall
Easy Medical Device Links TRAINING
Easy Medical Device Course Green Belt Certification program - November 21st to November 25th
Easy Medical Device Course EUDAMED training - November 30th with EirMed (Richard Houlihan)
Easy Medical Device Course Ronald Boumans Consulting: Training on PRRC
Easy Medical Device Course Book: Erik Vollebregt_ Enriched MDR and IVDR 2nd Edition
Easy Medical Device Links PODCAST
Easy Medical Device Podcast Episode 202: How to be MDSAP certified
Easy Medical Device Podcast Episode 203: Can you go to jail as a PRRC?

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