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Ähnelt Medical Device made Easy Podcast
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Medical Device News – November 2023 Regulatory Update
Manage episode 383659957 series 2591977
Inhalt bereitgestellt von Monir El Azzouzi. Alle Podcast-Inhalte, einschließlich Episoden, Grafiken und Podcast-Beschreibungen, werden direkt von Monir El Azzouzi oder seinem Podcast-Plattformpartner hochgeladen und bereitgestellt. Wenn Sie glauben, dass jemand Ihr urheberrechtlich geschütztes Werk ohne Ihre Erlaubnis nutzt, können Sie dem hier beschriebenen Verfahren folgen https://de.player.fm/legal.
EU:
- UDI for contact lenses Master-UDI-DI: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197
- EUDAMED Roadmap It is a DRAFT: https://health.ec.europa.eu/system/files/2023-10/md_eudamed_roadmap_en.pdf
- MDCG 2023-4 guidance – Validate the combination with hardware https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf
- Fees and charges payable to EMA: Expert Panel will cost you money : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_14057_2023_INIT
- Notified Bodies : Finland and Turkey
- Sertio Oy (Finland) IVDR: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1001622
- Notice Belgelendirme (1st Turkish Notified Body) MDR: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=82870fd17389fc19149f103e8121acdc82fea1af&group=NOTIFICATION
- Team-NB call for action to Manufacturers to apply: https://www.team-nb.org/wp-content/uploads/2023/10/Team-NB-PressRelease-Capacity-NotifiedBodies-during-transition-IVDR-MDR-October2023.pdf
Training for you
Increase your knowledge in QA RA :
- Vigilance Reporting in EU: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
- Audit readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
- Green Belt training: December 11th until December 15th: LINK
Spain:
- Implementation of the HTA : EU Health Technology Assessment Regulations: https://www.aemps.gob.es/la-aemps/de-la-teoria-a-la-practica-implementacion-del-reglamento-de-evaluacion-de-tecnologias-sanitarias-de-la-ue/
- Regulation 2021/2282 on health technology assessment: https://health.ec.europa.eu/publications/regulation-eu-20212282-health-technology-assessment_en
Switzerland:
- Products without an intended medical purpose : Same as EU MDR: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_007d_mb_produkte_ohne_medizinische_zweckbestimmung.pdf.download.pdf/MU600_00_007e_MB_Devices_without_an_intended_medical_purpose.pdf
- Obligation Economic Operators –: Update due to extension https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_016d_mb_pflichten_wirtschaftsakteure_ch.pdf.download.pdf/MU600_00_016e_MB_Obligations_Economic_Operators_CH.pdf
- General procedure for foreign governmental inspections – Inform Swissmedic before governments audit a manufacturer https://www.swissmedic.ch/dam/swissmedic/en/dokumente/bewilligungen/i-308/i-308_aa_02-A01e_general_procedure_for_foreign_governmental_inspections_switzerland.pdf.download.pdf/I-308.AA.02-A01e_Merkblatt_General_procedure_foreign_govern_insp_CH_related_therapeutic_prod.pdf
MedTech Conf
Map of conferences available
- Conferences Map: https://medtechconf.com/
- Medica Dusseldorf November 13 -15 : https://medtechconf.com/event/medica-2023/
- TEAM-PRRC Strasbourg November 16 – 17: https://medtechconf.com/event/team-prrc-annual-summit-2023/
Turkey:
- Product not considered as a Medical Device – List of products available: https://titck.gov.tr/duyuru/tibbi-cihaz-yonetmelikleri-kapsaminda-degerlendirilmeyen-urunler-30102023120556
eQMS SmartEye:
- SmartEye is your eQMS – Ask for your DEMO : https://smart-eye.io/
USA:
- eStar is your new 510k : Since October 1st, 2023: https://www.fda.gov/media/152429/download
Australia:
- Webinar on UDI for Australia – November 21st, 2023 11.30 AEDT: https://www.tga.gov.au/resources/event/webinars/unique-device-identification-udi-webinar-19-australian-udi-project-update-and-discussing-considerations-and-real-world-benefits-adopting-udi-healthcare
Podcast Nostalgia : You remember
- What are some pitfalls to avoid during Software Design? Weronika Michaluk: https://podcast.easymedicaldevice.com/253-2/
- Affrisummit 2023 Part 1 Morad Ajan, Rana Chalhoub, Dr. Mona Al Moussali: https://podcast.easymedicaldevice.com/254-2/
- Afrisummit 2023 Part 2 Nora El-Hariri and Mohamed Mahdy Ghonim: https://podcast.easymedicaldevice.com/255-2/
- Validate your iPhone, Samsung Galaxy, Huawei for your Software Erik Vollebregt: https://podcast.easymedicaldevice.com/256-2/
The post Medical Device News – November 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
311 Episoden
Teilen
Manage episode 383659957 series 2591977
Inhalt bereitgestellt von Monir El Azzouzi. Alle Podcast-Inhalte, einschließlich Episoden, Grafiken und Podcast-Beschreibungen, werden direkt von Monir El Azzouzi oder seinem Podcast-Plattformpartner hochgeladen und bereitgestellt. Wenn Sie glauben, dass jemand Ihr urheberrechtlich geschütztes Werk ohne Ihre Erlaubnis nutzt, können Sie dem hier beschriebenen Verfahren folgen https://de.player.fm/legal.
EU:
- UDI for contact lenses Master-UDI-DI: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197
- EUDAMED Roadmap It is a DRAFT: https://health.ec.europa.eu/system/files/2023-10/md_eudamed_roadmap_en.pdf
- MDCG 2023-4 guidance – Validate the combination with hardware https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf
- Fees and charges payable to EMA: Expert Panel will cost you money : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_14057_2023_INIT
- Notified Bodies : Finland and Turkey
- Sertio Oy (Finland) IVDR: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1001622
- Notice Belgelendirme (1st Turkish Notified Body) MDR: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=82870fd17389fc19149f103e8121acdc82fea1af&group=NOTIFICATION
- Team-NB call for action to Manufacturers to apply: https://www.team-nb.org/wp-content/uploads/2023/10/Team-NB-PressRelease-Capacity-NotifiedBodies-during-transition-IVDR-MDR-October2023.pdf
Training for you
Increase your knowledge in QA RA :
- Vigilance Reporting in EU: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
- Audit readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
- Green Belt training: December 11th until December 15th: LINK
Spain:
- Implementation of the HTA : EU Health Technology Assessment Regulations: https://www.aemps.gob.es/la-aemps/de-la-teoria-a-la-practica-implementacion-del-reglamento-de-evaluacion-de-tecnologias-sanitarias-de-la-ue/
- Regulation 2021/2282 on health technology assessment: https://health.ec.europa.eu/publications/regulation-eu-20212282-health-technology-assessment_en
Switzerland:
- Products without an intended medical purpose : Same as EU MDR: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_007d_mb_produkte_ohne_medizinische_zweckbestimmung.pdf.download.pdf/MU600_00_007e_MB_Devices_without_an_intended_medical_purpose.pdf
- Obligation Economic Operators –: Update due to extension https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_016d_mb_pflichten_wirtschaftsakteure_ch.pdf.download.pdf/MU600_00_016e_MB_Obligations_Economic_Operators_CH.pdf
- General procedure for foreign governmental inspections – Inform Swissmedic before governments audit a manufacturer https://www.swissmedic.ch/dam/swissmedic/en/dokumente/bewilligungen/i-308/i-308_aa_02-A01e_general_procedure_for_foreign_governmental_inspections_switzerland.pdf.download.pdf/I-308.AA.02-A01e_Merkblatt_General_procedure_foreign_govern_insp_CH_related_therapeutic_prod.pdf
MedTech Conf
Map of conferences available
- Conferences Map: https://medtechconf.com/
- Medica Dusseldorf November 13 -15 : https://medtechconf.com/event/medica-2023/
- TEAM-PRRC Strasbourg November 16 – 17: https://medtechconf.com/event/team-prrc-annual-summit-2023/
Turkey:
- Product not considered as a Medical Device – List of products available: https://titck.gov.tr/duyuru/tibbi-cihaz-yonetmelikleri-kapsaminda-degerlendirilmeyen-urunler-30102023120556
eQMS SmartEye:
- SmartEye is your eQMS – Ask for your DEMO : https://smart-eye.io/
USA:
- eStar is your new 510k : Since October 1st, 2023: https://www.fda.gov/media/152429/download
Australia:
- Webinar on UDI for Australia – November 21st, 2023 11.30 AEDT: https://www.tga.gov.au/resources/event/webinars/unique-device-identification-udi-webinar-19-australian-udi-project-update-and-discussing-considerations-and-real-world-benefits-adopting-udi-healthcare
Podcast Nostalgia : You remember
- What are some pitfalls to avoid during Software Design? Weronika Michaluk: https://podcast.easymedicaldevice.com/253-2/
- Affrisummit 2023 Part 1 Morad Ajan, Rana Chalhoub, Dr. Mona Al Moussali: https://podcast.easymedicaldevice.com/254-2/
- Afrisummit 2023 Part 2 Nora El-Hariri and Mohamed Mahdy Ghonim: https://podcast.easymedicaldevice.com/255-2/
- Validate your iPhone, Samsung Galaxy, Huawei for your Software Erik Vollebregt: https://podcast.easymedicaldevice.com/256-2/
The post Medical Device News – November 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
311 Episoden
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Ähnelt Medical Device made Easy Podcast
Alessandro Bogliari, CEO and Co-Founder of The Influencer Marketing Factory, a global influencer marketing agency, talks with great guests about influencer marketing, social media, the creator economy, social commerce and much more.
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continue reading
A top podcast for healthcare leaders, with over one million downloads, Radio Advisory is your weekly download on how to untangle the industry's most pressing challenges to help leaders like you make the best business decisions for your organization. From unpacking major trends in care delivery—like site-of-care shifts and the rise of high-cost drugs—to demystifying stakeholder dynamics, to shining a spotlight on priorities that may get overlooked, we're here to help. Our hosts and seasoned r ...
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continue reading
The traditional enterprise go-to-market motion is undergoing a transformational shift. B2B buyers are more sophisticated than ever, and operational efficiency is a key focus for every organization. One key function possesses a unique opportunity to shape the future of revenue generation: enablement. On this podcast, we’re bringing you the secrets, strategies, and tactics that successful enablement leaders are using to drive meaningful impact. The Enablement Edge is the go-to resource for sal ...
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Call them changemakers. Call them rule breakers. We call them Redefiners. And in this provocative podcast, we explore how daring leaders from across industries and around the globe are redefining their organizations—and themselves—to create extraordinary impact in today’s rapidly changing world. In each episode, Russell Reynolds Associates Leadership Advisor Hoda Tahoun and former CEO Clarke Murphy host engaging, purposeful conversations with leaders in and out of the business world who shar ...
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The Brutal Truth about Sales and Selling - We interview the world's best B2B Enterprise salespeople.
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No BS Allowed - Are you sick of empty suits telling you to work harder? - Learn about The Maverick Selling Method, which models the world's best salespeople and what they do differently. If you are in sales and are passionate about selling, you will like this podcast. The focus is on b2b sales and selling. If you are selling or in sales, this podcast is for you. I cover cold calling, spin selling, challenger sale, solution selling, and advanced selling skills. Strategic selling, LinkedIn, sa ...
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The best sales leaders in the world are revealing their points of view, playbooks, and tried and true tactics...only on Reveal: The Revenue Intelligence Podcast. Join us each month as host Dana Feldman digs deep into the world of the sales leaders she admires and aspires to be from some of the largest and most prominent organizations. Whether you're a CRO or aspiring to be one, these conversations will help you lead teams well, surpass revenue goals, and stay ahead of industry trends. Dana F ...
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The Greatness Machine is on a Quest to Maximize the Human Experience! Join Award Winning CEO and Author, Darius Mirshahzadeh (pron. Mer-shaw-za-day), as he interviews some of the greatest minds in the world―turning their wisdom and experience into learnings and advice you can use in your life so that you can level up and create greatness. Join Darius as he goes deep with guests like: Moby, Seth Godin, Gabby Reece, Amanda Knox, UFC Ring Announcer Bruce Buffer, Former FBI Negotiator Chris Voss ...
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