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Innehåll tillhandahållet av Monir El Azzouzi. Allt poddinnehåll inklusive avsnitt, grafik och podcastbeskrivningar laddas upp och tillhandahålls direkt av Monir El Azzouzi eller deras podcastplattformspartner. Om du tror att någon använder ditt upphovsrättsskyddade verk utan din tillåtelse kan du följa processen som beskrivs här https://sv.player.fm/legal.
Liknande Medical Device made Easy Podcast
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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Medical Device News, July 2024 Regulatory Update
Manage episode 427316697 series 2591977
Innehåll tillhandahållet av Monir El Azzouzi. Allt poddinnehåll inklusive avsnitt, grafik och podcastbeskrivningar laddas upp och tillhandahålls direkt av Monir El Azzouzi eller deras podcastplattformspartner. Om du tror att någon använder ditt upphovsrättsskyddade verk utan din tillåtelse kan du följa processen som beskrivs här https://sv.player.fm/legal.
Medboard
EU
- Germany warns against overregulation of Medical Devices – Is it not too late: https://www.bundestag.de/presse/hib/kurzmeldungen-1006422
- Title: MDR and IVDR next steps – Subtitle: Erik Vollebregt points: https://medicaldeviceslegal.com/2024/06/04/the-german-angle/
- MDCG 2022-13 Rev1 – Extension of the scope of designations: https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf
- MDCG 2024-10 Clinical Evaluation of orphan medical devices : For RARE DISEASES: https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf
- Scheer – Brain Stimuilators -: Risks associated with Brain Stimulators: https://health.ec.europa.eu/consultations/scheer-call-external-experts-scheer-wg-risks-health-associated-use-brain-stimulators-not-having_en
- Fast access to Clinical Trial Information -: New CTIS: https://www.ema.europa.eu/en/news/faster-access-clinical-trial-information-europe
- AI Supervision required – AI ACT: https://www.autoriteitpersoonsgegevens.nl/en/current/ap-and-rdi-supervision-of-ai-systems-requires-collaboration-and-must-be-arranged-quickly
UK
- UK USA and Canada on AI – Guiding Principles: https://assets.publishing.service.gov.uk/media/66670b9be8d5f2d4bdfcbb37/transparency_ml-enabled_devices_guiding_principles.pdf
Swiss
- SWISSDAMED Actors Module – Open in August 6th, 2024: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/release-notes.html
MEDTECH CONF
- Medicall August 2nd 2024 – Chennai, India: https://medtechconf.com/event/medicall-chennai-2024/
- RAPS Convergence Sept 17-19 2024 – Long Beach, California, USA: https://medtechconf.com/event/raps-convergence-2024/
- AI Act Summit October 1st 2024 – Strasbourg, France: https://medtechconf.com/event/ai-act-summit/
LIVE SESSION
- Medical Device Live Expert #1 – Replay: https://www.youtube.com/watch?v=RrzXj36Yrqc
- Medical Device Live Expert #2 – US is in the place: https://www.linkedin.com/events/medicaldeviceliveexpert-2-usais7214180765008359424/theater/
US
- Essential Drug Delivery Outputs for Devices Guidance – Learn FDA requirements for EDDOs: https://www.fda.gov/media/179545/download
- Recognized Standards – Change happens: https://www.govinfo.gov/content/pkg/FR-2024-06-24/pdf/2024-13777.pdf
- US Webinar IVD classification -: July 16th 1pm EST: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-in-vitro-diagnostic-product-ivd-classification-07162024
- Blog post – The promise of AI in Health Care – FDA knows: https://www.fda.gov/medical-devices/digital-health-center-excellence/blog-promise-artificial-intelligence-holds-improving-health-care
Australia
- Australia: Exempt Medical Device – They should still follow the rules: https://www.tga.gov.au/resources/resource/guidance/regulatory-obligation-exempt-medical-devices
- Cosmetics or therapeutics -TGA helps you to decide: https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf
- : Essential Principle Checklist -Template available: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist
- AusUDID is in the place – Australian UDI Database for sponsors and manufacturers: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/australian-udi-database-sponsors-and-manufacturers
Saudi Arabia
- Extend Shelf Life – in case of Public emergency: https://tinyurl.com/EMDpod
Malaysia
- Workshop Post-Market Requirements – July 16th, 2024: https://www.autoriteitpersoonsgegevens.nl/en/current/ap-and-rdi-supervision-of-ai-systems-requires-collaboration-and-must-be-arranged-quickly
- Training: How to submit documents – July 17th, 2024: https://portal.mda.gov.my/index.php/doclink/program-8-hands-on-medcrest-post-market-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJwcm9ncmFtLTgtaGFuZHMtb24tbWVkY3Jlc3QtcG9zdC1tYXJrZXQtcGRmIiwiaWF0IjoxNzE4MjQ5OTgzLCJleHAiOjE3MTgzMzYzODN9._ZObFPlzSpQWnAoPKDxH_J8IWhmcTDNLsFpYe0AkO9M
- Are you satisfied with Malaysia MDA – You can rate here: https://www.mda.gov.my/index.php/news/1418-kajian-kepuasan-pelanggan-mda-1-2024
South Africa
- SAHPRA Medical Device Vigilance- Who to contact: https://www.sahpra.org.za/wp-content/uploads/2024/06/Contacts-for-Adverse-Events-Recalls-and-Market-Actions.pdf
PODCAST
- Episode 288 – Cleaning Validation – How to select the worst case (Heena Thakkar): https://podcast.easymedicaldevice.com/288-2/
- Episode 289 – AFNOR- How is a Notified Body designated: (Thomas Lommatzsch): https://podcast.easymedicaldevice.com/289-2/
- Episode 290 – How to submit your AI/ML SAMD the right way? (Richie Christian): https://podcast.easymedicaldevice.com/290-2/
Social Media to follow
- Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
- Twitter: https://twitter.com/elazzouzim
- Pinterest: https://www.pinterest.com/easymedicaldevice
- Instagram: https://www.instagram.com/easymedicaldevice
The post Medical Device News, July 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
311 episoder
Dela
Manage episode 427316697 series 2591977
Innehåll tillhandahållet av Monir El Azzouzi. Allt poddinnehåll inklusive avsnitt, grafik och podcastbeskrivningar laddas upp och tillhandahålls direkt av Monir El Azzouzi eller deras podcastplattformspartner. Om du tror att någon använder ditt upphovsrättsskyddade verk utan din tillåtelse kan du följa processen som beskrivs här https://sv.player.fm/legal.
Medboard
EU
- Germany warns against overregulation of Medical Devices – Is it not too late: https://www.bundestag.de/presse/hib/kurzmeldungen-1006422
- Title: MDR and IVDR next steps – Subtitle: Erik Vollebregt points: https://medicaldeviceslegal.com/2024/06/04/the-german-angle/
- MDCG 2022-13 Rev1 – Extension of the scope of designations: https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf
- MDCG 2024-10 Clinical Evaluation of orphan medical devices : For RARE DISEASES: https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf
- Scheer – Brain Stimuilators -: Risks associated with Brain Stimulators: https://health.ec.europa.eu/consultations/scheer-call-external-experts-scheer-wg-risks-health-associated-use-brain-stimulators-not-having_en
- Fast access to Clinical Trial Information -: New CTIS: https://www.ema.europa.eu/en/news/faster-access-clinical-trial-information-europe
- AI Supervision required – AI ACT: https://www.autoriteitpersoonsgegevens.nl/en/current/ap-and-rdi-supervision-of-ai-systems-requires-collaboration-and-must-be-arranged-quickly
UK
- UK USA and Canada on AI – Guiding Principles: https://assets.publishing.service.gov.uk/media/66670b9be8d5f2d4bdfcbb37/transparency_ml-enabled_devices_guiding_principles.pdf
Swiss
- SWISSDAMED Actors Module – Open in August 6th, 2024: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/release-notes.html
MEDTECH CONF
- Medicall August 2nd 2024 – Chennai, India: https://medtechconf.com/event/medicall-chennai-2024/
- RAPS Convergence Sept 17-19 2024 – Long Beach, California, USA: https://medtechconf.com/event/raps-convergence-2024/
- AI Act Summit October 1st 2024 – Strasbourg, France: https://medtechconf.com/event/ai-act-summit/
LIVE SESSION
- Medical Device Live Expert #1 – Replay: https://www.youtube.com/watch?v=RrzXj36Yrqc
- Medical Device Live Expert #2 – US is in the place: https://www.linkedin.com/events/medicaldeviceliveexpert-2-usais7214180765008359424/theater/
US
- Essential Drug Delivery Outputs for Devices Guidance – Learn FDA requirements for EDDOs: https://www.fda.gov/media/179545/download
- Recognized Standards – Change happens: https://www.govinfo.gov/content/pkg/FR-2024-06-24/pdf/2024-13777.pdf
- US Webinar IVD classification -: July 16th 1pm EST: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-in-vitro-diagnostic-product-ivd-classification-07162024
- Blog post – The promise of AI in Health Care – FDA knows: https://www.fda.gov/medical-devices/digital-health-center-excellence/blog-promise-artificial-intelligence-holds-improving-health-care
Australia
- Australia: Exempt Medical Device – They should still follow the rules: https://www.tga.gov.au/resources/resource/guidance/regulatory-obligation-exempt-medical-devices
- Cosmetics or therapeutics -TGA helps you to decide: https://www.tga.gov.au/sites/default/files/2024-06/cosmetics-therapeutic-goods-guidance-for-advertisers-suppliers.pdf
- : Essential Principle Checklist -Template available: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist
- AusUDID is in the place – Australian UDI Database for sponsors and manufacturers: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/australian-udi-database-sponsors-and-manufacturers
Saudi Arabia
- Extend Shelf Life – in case of Public emergency: https://tinyurl.com/EMDpod
Malaysia
- Workshop Post-Market Requirements – July 16th, 2024: https://www.autoriteitpersoonsgegevens.nl/en/current/ap-and-rdi-supervision-of-ai-systems-requires-collaboration-and-must-be-arranged-quickly
- Training: How to submit documents – July 17th, 2024: https://portal.mda.gov.my/index.php/doclink/program-8-hands-on-medcrest-post-market-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJwcm9ncmFtLTgtaGFuZHMtb24tbWVkY3Jlc3QtcG9zdC1tYXJrZXQtcGRmIiwiaWF0IjoxNzE4MjQ5OTgzLCJleHAiOjE3MTgzMzYzODN9._ZObFPlzSpQWnAoPKDxH_J8IWhmcTDNLsFpYe0AkO9M
- Are you satisfied with Malaysia MDA – You can rate here: https://www.mda.gov.my/index.php/news/1418-kajian-kepuasan-pelanggan-mda-1-2024
South Africa
- SAHPRA Medical Device Vigilance- Who to contact: https://www.sahpra.org.za/wp-content/uploads/2024/06/Contacts-for-Adverse-Events-Recalls-and-Market-Actions.pdf
PODCAST
- Episode 288 – Cleaning Validation – How to select the worst case (Heena Thakkar): https://podcast.easymedicaldevice.com/288-2/
- Episode 289 – AFNOR- How is a Notified Body designated: (Thomas Lommatzsch): https://podcast.easymedicaldevice.com/289-2/
- Episode 290 – How to submit your AI/ML SAMD the right way? (Richie Christian): https://podcast.easymedicaldevice.com/290-2/
Social Media to follow
- Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
- Twitter: https://twitter.com/elazzouzim
- Pinterest: https://www.pinterest.com/easymedicaldevice
- Instagram: https://www.instagram.com/easymedicaldevice
The post Medical Device News, July 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
311 episoder
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Liknande 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.
…
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 ...
…
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 ...
…
continue reading
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 ...
…
continue reading
1
The Brutal Truth about Sales and Selling - We interview the world's best B2B Enterprise salespeople.
Brian Burns
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 ...
…
continue reading
How do I start an online business? How do I build a brand online? How do I get traffic and attention to my online business? The biggest question is, can I start a business online and replace my current JOB? Welcome to The Rock Your Brand podcast show where we answer ALL of these questions and a ton MORE! Scott Voelker, the host will share with you everything you need to know and help you to build a Future Proof Business that will allow you the ultimate Freedom. Scott shares tips and strategi ...
…
continue reading
Kipp Bodnar (HubSpot’s CMO) and Kieran Flanagan (Zapier’s CMO), lead you down the rabbit hole of marketing trends, growth tactics and innovation. On the way you’ll pick up undiscovered strategies to give you that slight edge for success. These are not your typical twitter thread regurgitated marketing tactics that everyone is doing. These are new methods, with unfiltered examination of successful fresh ideas.
…
continue reading
The Partnership Economy explores the power of partnerships through candid conversations and stories with industry leaders. Our hosts, David A. Yovanno, CEO and Todd Crawford, Co-founder, of impact.com, unpack the future of partnerships as a lever for scale and an opportunity to put the consumer first.
…
continue reading
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 ...
…
continue reading
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