Medical Device News february 2024 Regulatory Update

• Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!:
o Measures:
o Question and Answers:
o Factsheet:
• MDCG 2024-1 Vigilance System for CE – Guidance and Template:
o MDCG 2024-1-1 Device for Cardiac Ablation:
o MDCG 2024-1-2 Coronary Stents and associated delivery systems:
o MDCG 2024-1-3 Cardiac Implantable Electronic Devices (CIEDs):
o MDCG 2024-1-4 Breast Implants:
• Language requirements for Manufacturers (MDR & IVDR) – Check where English is not applicable:
o MDR:
• your eQMS SmartEye – The best eQMS ever:

• Future Regulation roadmap – We still have to wait:

• Training EU MDR Green Belt – February and March 2024 :

Notified Bodies and Approved Bodies
• UK Approved bodies – They are 9 now:
o Scarlet NB UK:

GDP video
• Good Documentation Practices – Check how to be sure to have good documents:

o US FDA Quality Management System Regulation – Alignment to ISO 13485:
o US FDA IVD Reclassification – Move from Class III to Class II:
o FDA Remote Regulatory Assessment (RRA) – Question and Answers:
o Estar 5.1 version -: IVD and non-IVD:
• Non-IVD:
• IVD:
• eStar 5.0 video with Rob Packard:
• Saudi Arabia
o Webinar: Artificial Intelligence and Software -:February 13th, 2024 at 10 AM Middle East time :

o Manufacturing Devices at Point of Care (PoC) – uidance on how to manufacture them:

• Medtech Conf – RAPS Workshop – Feb 27th until March 1st:

Title: Podcast Nostalgia – Relisten again and again
• Episode 267 – Warning! Apply to your Notified Body Now! with Pritam Mekala:
• Episode 268 – You are not the Physical Manufacturer, can you be MDR certified:
• Episode 269 – Why you should use Pre-Submission or Q-Sub with FDA:

Whatsapp Community:
• Whatsapp community – Register even if it says no:


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