EU
• Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: [ Ссылка ]
o Measures: [ Ссылка ]
o Question and Answers: [ Ссылка ]
o Factsheet: [ Ссылка ]
• MDCG 2024-1 Vigilance System for CE - Guidance and Template: [ Ссылка ]
o MDCG 2024-1-1 Device for Cardiac Ablation: [ Ссылка ]
o MDCG 2024-1-2 Coronary Stents and associated delivery systems: [ Ссылка ]
o MDCG 2024-1-3 Cardiac Implantable Electronic Devices (CIEDs): [ Ссылка ]
o MDCG 2024-1-4 Breast Implants: [ Ссылка ]
• Language requirements for Manufacturers (MDR & IVDR) - Check where English is not applicable:
o MDR: [ Ссылка ]
o IVDR: [ Ссылка ]
eQMS
• your eQMS SmartEye - The best eQMS ever: [ Ссылка ]
UK
• Future Regulation roadmap - We still have to wait: [ Ссылка ]
Course
• Training EU MDR Green Belt - February and March 2024 : [ Ссылка ]
Notified Bodies and Approved Bodies
• UK Approved bodies - They are 9 now: [ Ссылка ]
o LNE-GMED: [ Ссылка ]
o Scarlet NB UK: [ Ссылка ]
GDP video
• Good Documentation Practices - Check how to be sure to have good documents: [ Ссылка ]
ROW
• USA
o US FDA Quality Management System Regulation - Alignment to ISO 13485: [ Ссылка ]
o US FDA IVD Reclassification - Move from Class III to Class II: [ Ссылка ]
o FDA Remote Regulatory Assessment (RRA) - Question and Answers: [ Ссылка ]
o Estar 5.1 version -: IVD and non-IVD: [ Ссылка ]
• Non-IVD: [ Ссылка ]
• IVD: [ Ссылка ]
• eStar 5.0 video with Rob Packard: [ Ссылка ]
• Saudi Arabia
o Webinar: Artificial Intelligence and Software -:February 13th, 2024 at 10 AM Middle East time : [ Ссылка ]
•
o Manufacturing Devices at Point of Care (PoC) - uidance on how to manufacture them: [ Ссылка ]
Events
• Medtech Conf - RAPS Workshop - Feb 27th until March 1st: [ Ссылка ]
Title: Podcast Nostalgia - Relisten again and again
• Episode 267 - Warning! Apply to your Notified Body Now! with Pritam Mekala: [ Ссылка ]
• Episode 268 - You are not the Physical Manufacturer, can you be MDR certified: [ Ссылка ]
• Episode 269 - Why you should use Pre-Submission or Q-Sub with FDA: [ Ссылка ]
Whatsapp Community:
• Whatsapp community - Register even if it says no: [ Ссылка ]
