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Konten disediakan oleh Monir El Azzouzi. Semua konten podcast termasuk episode, grafik, dan deskripsi podcast diunggah dan disediakan langsung oleh Monir El Azzouzi atau mitra platform podcast mereka. Jika Anda yakin seseorang menggunakan karya berhak cipta Anda tanpa izin, Anda dapat mengikuti proses yang diuraikan di sini https://id.player.fm/legal.
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Medical Device News March 2024 Regulatory Update
Manage episode 404874303 series 2591977
Konten disediakan oleh Monir El Azzouzi. Semua konten podcast termasuk episode, grafik, dan deskripsi podcast diunggah dan disediakan langsung oleh Monir El Azzouzi atau mitra platform podcast mereka. Jika Anda yakin seseorang menggunakan karya berhak cipta Anda tanpa izin, Anda dapat mengikuti proses yang diuraikan di sini https://id.player.fm/legal.
EU
- EU proposal to prevent shortage – And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/
- Notified Body Survey – Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf
- Spain: AEMPS consultation – Qualification and Classification of Medical Devices: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-un-procedimiento-para-consultas-relativas-a-la-cualificacion-y-clasificacion-de-productos-sanitarios-incluidos-los-de-diagnostico-in-vitro/
- EURL Second Call – More Lab for High Risk IVD: https://health.ec.europa.eu/latest-updates/expression-interest-open-possible-second-call-eu-reference-laboratories-high-risk-vitro-diagnostic-2024-02-22_en
- TEAM-NB Position Paper – Reclassification of IVD: https://www.team-nb.org/wp-content/uploads/2024/03/Team-NB-PositionPaper-Classification-of-SARS-Cov2-20240202.pdf
- EMDN Proposal – Suggest your updates: https://webgate.ec.europa.eu/dyna2/emdn/
- Does your product qualify for CECP -Notified Bodies should decide: https://www.ema.europa.eu/en/documents/other/working-instructions-notified-bodies-application-article-54-regulation-eu-2017-745-medical-devices-article-48-regulation-eu-2017-746-vitro-diagnostic-medical-devices_en.pdf
Training
- Training Green Belt EU MDR – Learn by practicing: https://school.easymedicaldevice.com/course/gb30
- Open March 25th, 2024 until March 29th, 2024
- TEAM-NB Training – Technical Documentation: https://www.team-nb.org/wp-content/uploads/2024/02/Leaflet-MDR-TD-Manufacturers-Training-20240429.pdf
- April 29th, 2024
Services
- Packaging and IFU – Design and Production: https://easymedicaldevice.com/packaging-for-medical-devices/
ROW
USA
- Fraudulent Lab -: FDA ask you to check your Third Party: https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-fda-reminds-medical-device
CANADA
- Consultation on Significant Changes -: Until April 22nd, 2024: https://www.canada.ca/en/health-canada/programs/draft-guidance-how-to-interpret-significant-change-medical-device.html
Mexico
- Mexico to Strengthen the Medical Device industry -: Harmonization planned with other Regulatory Pathways: https://www.gob.mx/cofepris/articulos/cofepris-presenta-agenda-de-fortalecimiento-de-la-industria-de-dispositivos-medicos?idiom=es
Saudi Arabia
- SFDA Harmonized Standards – Which one is accepted?: https://www.sfda.gov.sa/sites/default/files/2024-02/MDS%E2%80%93G020.pdf
Qatar
- Qatar Telemedicine – Policy to use this technology: https://www.moph.gov.qa/_layouts/15/download.aspx?SourceUrl=/Admin/Lists/Announcements%20Attachments/Attachments/275/Tele%20Policy.pdf
Australia
- TGA SOPP requirements – System or Procedure Pack guidance: https://www.tga.gov.au/sites/default/files/2024-02/system-procedure-packs-guidance-sponsors-manufacturers-charities.pdf
- TGA Essential Principles – Template available: https://www.tga.gov.au/sites/default/files/essential-principles-checklist-medical-devices.pdf
- Transition to EU MDR cases – Evidence of transition, DCR, Non-Compliance, Recalls:
- https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-dcrs-and-variations-case-studies-and-scenarios.pdf
- https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-conformity-assessment-essential-principles-case-studies-and-scenarios.pdf
- https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-manufacturer-evidence-case-studies-and-scenarios.pdf
- https://www.tga.gov.au/sites/default/files/2024-02/eu-mdr-recalls-and-market-notifications-case-studies-and-scenarios.pdf
PODCAST
- Episode 271 – How to get your interview prepared? With Elena Kyria https://podcast.easymedicaldevice.com/271-2/
- Episode 272 – Will EtO gaz become a Medical Device? Christina Ziegenberg: https://podcast.easymedicaldevice.com/272-2/
- Episode 272 – New EU Proposal, EUDAMED, Shortage and IVDR transition. Erik Vollebregt: https://podcast.easymedicaldevice.com/273-3/
EASY MEDICAL DEVICE Services:
- Training: https://school.easymedicaldevice.com/emd-course/
- Authorized Representative EU: https://easymedicaldevice.com/eu-rep/
- Authorized Representative UK: https://easymedicaldevice.com/uk-responsible-person/
- Authorized Representative Swiss: https://easymedicaldevice.com/swiss-authorised-representative/
- Backoffice Services: https://easymedicaldevice.com/backoffice-service-medical-device/
- Eqms SmartEye; https://smart-eye.io
- Conferences: https://medtechconf.com/
The post Medical Device News March 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
292 episode
Bagikan
Manage episode 404874303 series 2591977
Konten disediakan oleh Monir El Azzouzi. Semua konten podcast termasuk episode, grafik, dan deskripsi podcast diunggah dan disediakan langsung oleh Monir El Azzouzi atau mitra platform podcast mereka. Jika Anda yakin seseorang menggunakan karya berhak cipta Anda tanpa izin, Anda dapat mengikuti proses yang diuraikan di sini https://id.player.fm/legal.
EU
- EU proposal to prevent shortage – And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/
- Notified Body Survey – Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf
- Spain: AEMPS consultation – Qualification and Classification of Medical Devices: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-un-procedimiento-para-consultas-relativas-a-la-cualificacion-y-clasificacion-de-productos-sanitarios-incluidos-los-de-diagnostico-in-vitro/
- EURL Second Call – More Lab for High Risk IVD: https://health.ec.europa.eu/latest-updates/expression-interest-open-possible-second-call-eu-reference-laboratories-high-risk-vitro-diagnostic-2024-02-22_en
- TEAM-NB Position Paper – Reclassification of IVD: https://www.team-nb.org/wp-content/uploads/2024/03/Team-NB-PositionPaper-Classification-of-SARS-Cov2-20240202.pdf
- EMDN Proposal – Suggest your updates: https://webgate.ec.europa.eu/dyna2/emdn/
- Does your product qualify for CECP -Notified Bodies should decide: https://www.ema.europa.eu/en/documents/other/working-instructions-notified-bodies-application-article-54-regulation-eu-2017-745-medical-devices-article-48-regulation-eu-2017-746-vitro-diagnostic-medical-devices_en.pdf
Training
- Training Green Belt EU MDR – Learn by practicing: https://school.easymedicaldevice.com/course/gb30
- Open March 25th, 2024 until March 29th, 2024
- TEAM-NB Training – Technical Documentation: https://www.team-nb.org/wp-content/uploads/2024/02/Leaflet-MDR-TD-Manufacturers-Training-20240429.pdf
- April 29th, 2024
Services
- Packaging and IFU – Design and Production: https://easymedicaldevice.com/packaging-for-medical-devices/
ROW
USA
- Fraudulent Lab -: FDA ask you to check your Third Party: https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-fda-reminds-medical-device
CANADA
- Consultation on Significant Changes -: Until April 22nd, 2024: https://www.canada.ca/en/health-canada/programs/draft-guidance-how-to-interpret-significant-change-medical-device.html
Mexico
- Mexico to Strengthen the Medical Device industry -: Harmonization planned with other Regulatory Pathways: https://www.gob.mx/cofepris/articulos/cofepris-presenta-agenda-de-fortalecimiento-de-la-industria-de-dispositivos-medicos?idiom=es
Saudi Arabia
- SFDA Harmonized Standards – Which one is accepted?: https://www.sfda.gov.sa/sites/default/files/2024-02/MDS%E2%80%93G020.pdf
Qatar
- Qatar Telemedicine – Policy to use this technology: https://www.moph.gov.qa/_layouts/15/download.aspx?SourceUrl=/Admin/Lists/Announcements%20Attachments/Attachments/275/Tele%20Policy.pdf
Australia
- TGA SOPP requirements – System or Procedure Pack guidance: https://www.tga.gov.au/sites/default/files/2024-02/system-procedure-packs-guidance-sponsors-manufacturers-charities.pdf
- TGA Essential Principles – Template available: https://www.tga.gov.au/sites/default/files/essential-principles-checklist-medical-devices.pdf
- Transition to EU MDR cases – Evidence of transition, DCR, Non-Compliance, Recalls:
- https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-dcrs-and-variations-case-studies-and-scenarios.pdf
- https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-conformity-assessment-essential-principles-case-studies-and-scenarios.pdf
- https://www.tga.gov.au/sites/default/files/2022-12/eu-mdr-transition-manufacturer-evidence-case-studies-and-scenarios.pdf
- https://www.tga.gov.au/sites/default/files/2024-02/eu-mdr-recalls-and-market-notifications-case-studies-and-scenarios.pdf
PODCAST
- Episode 271 – How to get your interview prepared? With Elena Kyria https://podcast.easymedicaldevice.com/271-2/
- Episode 272 – Will EtO gaz become a Medical Device? Christina Ziegenberg: https://podcast.easymedicaldevice.com/272-2/
- Episode 272 – New EU Proposal, EUDAMED, Shortage and IVDR transition. Erik Vollebregt: https://podcast.easymedicaldevice.com/273-3/
EASY MEDICAL DEVICE Services:
- Training: https://school.easymedicaldevice.com/emd-course/
- Authorized Representative EU: https://easymedicaldevice.com/eu-rep/
- Authorized Representative UK: https://easymedicaldevice.com/uk-responsible-person/
- Authorized Representative Swiss: https://easymedicaldevice.com/swiss-authorised-representative/
- Backoffice Services: https://easymedicaldevice.com/backoffice-service-medical-device/
- Eqms SmartEye; https://smart-eye.io
- Conferences: https://medtechconf.com/
The post Medical Device News March 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
292 episode
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Mirip dengan Medical Device made Easy Podcast
Ever wondered what makes great go-to-market leaders grow, even when the going gets tough? We have, too. And we’re on a mission to uncover the magic that makes that growth happen. This is Go-to-Market Magic, the show where we talk to go-to-market leaders and visionaries about the “aha!” moments they experience and the pivotal decisions they’ve made, all in the name of growth. And we’re not just talking about revenue growth that goes up and to the right — we’ll also discuss how they improve th ...
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continue reading
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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 ...
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Tired of management theory? Want to learn specific skills to help improve your management performance? Then Manager Tools is the podcast for you! Manager Tools is a weekly business podcast focused on helping professionals become more effective managers and leaders. Each week, we discuss specific actions for professionals to take to achieve their desired management and career objectives. Manager Tools won Best Business Podcast Award in 2006, 2007, 2008, and 2012 as well as the People's Choice ...
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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.
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continue reading
Radio Advisory is your weekly download on how to untangle healthcare's most pressing challenges, powered by 40 years of Advisory Board research. Whether it's workforce shortages, industry disruptors, or health equity strategy, we're here to help. Our hosts and seasoned researchers talk with industry experts to equip you with knowledge to confront today’s unanswered questions in healthcare. New episodes drop every Tuesday. | www.advisory.com
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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 ...
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continue reading
Welcome to an exciting new season of the podcast Your Career: Choice or Chance? - as we dive into the ever-evolving world of GenAI in the Workplace and explore the latest trends, experiences, and career journeys shaping the future of work as AI is increasingly ingrained in it. Each episode provides fresh insights, addressing the transformative influence of GenAI in shaping the workforce of tomorrow, making it a must-listen for anyone interested in staying ahead in the ever-evolving world of ...
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continue reading
The American healthcare system is one of the most innovative in the world. But it’s also riddled with complex challenges, such as access to affordable medications, inefficiency and administrative burdens, and communication barriers between providers. There’s clearly a better way—and at Surescripts, we have a unique sightline into what that may be. In this series, host Melanie Marcus, Chief Marketing Officer of Surescripts, sits down with today’s most inspiring and innovative leaders in healt ...
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continue reading
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
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