Sponsor:
•Medboard
EU
•EU proposal to prevent shortage - And other things: [ Ссылка ]
•Notified Body Survey - Interesting statistics: [ Ссылка ]
•Spain: AEMPS consultation - Qualification and Classification of Medical Devices: [ Ссылка ]
•EURL Second Call - More Lab for High Risk IVD: [ Ссылка ]
•TEAM-NB Position Paper - Reclassification of IVD: [ Ссылка ]
•EMDN Proposal - Suggest your updates: [ Ссылка ]
oMDCG 2024-2 : [ Ссылка ]
•Does your product qualify for CECP -Notified Bodies should decide: [ Ссылка ]
Training
•Training Green Belt EU MDR - Learn by practicing: [ Ссылка ]
oOpen March 25th, 2024 until March 29th, 2024
•TEAM-NB Training - Technical Documentation: [ Ссылка ]
oApril 29th, 2024
Services
•Packaging and IFU - Design and Production: [ Ссылка ]
ROW
USA
•Fraudulent Lab -: FDA ask you to check your Third Party: [ Ссылка ]
CANADA
•Consultation on Significant Changes -: Until April 22nd, 2024: [ Ссылка ]
oDraft Guidance: [ Ссылка ]
Mexico
•Mexico to Strengthen the Medical Device industry -: Harmonization planned with other Regulatory Pathways: [ Ссылка ]
Saudi Arabia
• SFDA Harmonized Standards - Which one is accepted?: [ Ссылка ]
Qatar
• Qatar Telemedicine -Policy to use this technology: [ Ссылка ]
Australia
•TGA SOPP requirements -System or Procedure Pack guidance: [ Ссылка ]
•TGA Essential Principles -Template available: [ Ссылка ]
•Transition to EU MDR cases - Evidence of transition, DCR, Non-Compliance, Recalls:
ohttps://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-dcrs-and-variations-case-studies-and-scenarios.pdf
ohttps://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-conformity-assessment-essential-principles-case-studies-and-scenarios.pdf
ohttps://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-manufacturer-evidence-case-studies-and-scenarios.pdf
ohttps://www.tga.gov.au/sites/default/files/2024-02/eu-mdr-recalls-and-market-notifications-case-studies-and-scenarios.pdf
PODCAST
•Episode 271-How to get your interview prepared? With Elena Kyria [ Ссылка ]
•Episode 272 -Will EtO gaz become a Medical Device? Christina Ziegenberg: [ Ссылка ]
•Episode 272 -New EU Proposal, EUDAMED, Shortage and IVDR transition. Erik Vollebregt: [ Ссылка ]
EASY MEDICAL DEVICE Services:
•Training: [ Ссылка ]
•Authorized Representative EU: [ Ссылка ]
•Authorized Representative UK: [ Ссылка ]
•Authorized Representative Swiss: [ Ссылка ]
•Backoffice Services: [ Ссылка ]
•Eqms SmartEye; [ Ссылка ]
•Conferences: [ Ссылка ]
