×

Home Top Podcaster Networks By Language By Country By Category About Us Contact Us Faqs Features News & Blogs Privacy Policy Terms Of Use

☰

Search

Home > Medical Device made Easy Podcast > Medical Device News february 2024 Regulatory Update


	Podcast:		Medical Device made Easy Podcast
	Episode:		Medical Device News february 2024 Regulatory Update
	Category:		Business
	Duration:		00:00:00
	Publish Date:		2024-02-07 09:15:33
	Description:		EU Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-proposal.PDF Measures: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_24_346/IP_24_346_EN.pdf Question and Answers: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_24_347/QANDA_24_347_EN.pdf Factsheet: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-factsheet_1.pdf MDCG 2024-1 Vigilance System for CE – Guidance and Template: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1_en.pdf MDCG 2024-1-1 Device for Cardiac Ablation: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-1_en.pdf MDCG 2024-1-2 Coronary Stents and associated delivery systems: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-2_en.pdf MDCG 2024-1-3 Cardiac Implantable Electronic Devices (CIEDs): https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-3_en.pdf MDCG 2024-1-4 Breast Implants: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-4_en.pdf Language requirements for Manufacturers (MDR & IVDR) – Check where English is not applicable: MDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-mdr.pdf IVDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-ivdr.pdf eQMS your eQMS SmartEye – The best eQMS ever: https://eqms-smarteye.com UK Future Regulation roadmap – We still have to wait: https://assets.publishing.service.gov.uk/media/659d3539aaae22001356dc3c/Roadmap_towards_the_future_regulatory_framework_for_medical_devices__Jan_24.pdf Course Training EU MDR Green Belt – February and March 2024 : https://school.easymedicaldevice.com/gb/ Notified Bodies and Approved Bodies UK Approved bodies – They are 9 now: https://www.gov.uk/government/news/mhra-announces-two-new-uk-approved-bodies-to-certify-medical-devices LNE-GMED: https://assets.publishing.service.gov.uk/media/65b799f2a0ae1b000d52616e/LNE-GMED_Scope_Medical_Devices.pdf Scarlet NB UK: https://assets.publishing.service.gov.uk/media/65b79a11a0ae1b000d52616f/AB_Scarlet_Scope_Jan_2024.pdf GDP video Good Documentation Practices – Check how to be sure to have good documents: https://www.youtube.com/watch?v=nkBpef5AstI ROW USA US FDA Quality Management System Regulation – Alignment to ISO 13485: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked US FDA IVD Reclassification – Move from Class III to Class II: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-intent-initiate-reclassification-process-most-high-risk-ivds FDA Remote Regulatory Assessment (RRA) – Question and Answers: https://www.fda.gov/media/160173/download Estar 5.1 version -: IVD and non-IVD: https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program Non-IVD: https://www.fda.gov/media/174458/download?attachment IVD: https://www.fda.gov/media/174459/download?attachment eStar 5.0 video with Rob Packard: https://www.youtube.com/watch?v=KDkKnRnBfgc Saudi Arabia Webinar: Artificial Intelligence and Software -:February 13th, 2024 at 10 AM Middle East time : https://www.sfda.gov.sa/en/workshop/93262 Manufacturing Devices at Point of Care (PoC) – uidance on how to manufacture them: https://www.sfda.gov.sa/sites/default/files/2024-01/MDS%20–%20G009E.pdf Events Medtech Conf – RAPS Workshop – Feb 27th until March 1st: https://medtechconf.com/event/raps-events/ Podcast Nostalgia – Relisten again and again Episode 267 – Warning! Apply to your Notified Body Now! with Pritam Mekala: https://podcast.easymedicaldevice.com/267-2/ Episode 268 – You are not the Physical Manufacturer, can you be MDR certified: https://podcast.easymedicaldevice.com/268-2/ Episode 269 – Why you should use Pre-Submission or Q-Sub with FDA: https://podcast.easymedicaldevice.com/269-2/ Whatsapp Community: Whatsapp community – Register even if it says no: https://chat.whatsapp.com/DvpnuGLihD98zGXsiYicQq The post Medical Device News february 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
	Total Play:		0