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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コンテンツは Monir El Azzouzi によって提供されます。エピソード、グラフィック、ポッドキャストの説明を含むすべてのポッドキャスト コンテンツは、Monir El Azzouzi またはそのポッドキャスト プラットフォーム パートナーによって直接アップロードされ、提供されます。誰かがあなたの著作物をあなたの許可なく使用していると思われる場合は、ここで概説されているプロセスに従うことができますhttps://ja.player.fm/legal。
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How can business help solve society’s biggest challenges? Welcome to Series 3 of Take on Tomorrow, the award-winning podcast from PwC that examines the biggest problems facing society and the role business can—and should—play in solving them. This series, we’re welcoming broadcaster and journalist Femi Oke to the show. She joins podcaster and journalist Lizzie O’Leary, and together with industry innovators, tech trailblazers and visionary leaders from around the globe, they’ll explore timely ...
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Medical Device News, October 2024 Regulatory Update
Manage episode 444420129 series 2591977
コンテンツは Monir El Azzouzi によって提供されます。エピソード、グラフィック、ポッドキャストの説明を含むすべてのポッドキャスト コンテンツは、Monir El Azzouzi またはそのポッドキャスト プラットフォーム パートナーによって直接アップロードされ、提供されます。誰かがあなたの著作物をあなたの許可なく使用していると思われる場合は、ここで概説されているプロセスに従うことができますhttps://ja.player.fm/legal。
Medboard: https://www.medboard.com/
EUROPE
- TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf
- TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf
- MDCG 2021-4 Rev 1 update- Deletion, revision, addition of questions: https://health.ec.europa.eu/document/download/9f23fca0-f407-4e45-a464-2d71b575d1fe_en?filename=mdcg_2021-4_en.pdf
- Swissmedic – Deadline for Swissdamed – November 13th, 2024: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/archive/swissdamed/swissdamed-frist-13-11-24.html
- Swiss review of old legislation devices – Check that all are up-to-date: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/aufforderung-ueberpruefung-altrechtlicher-produkte.html
- UK on their new Regulation – Restart ongoing: https://medregs.blog.gov.uk/2024/09/25/an-update-on-our-plans-for-med-tech-regulatory-change/
EVENTS
- TEAM-PRRC – October 17-18. 2024: https://medtechconf.com/event/team-prrc-third-annual-summit/
- Afrisummit – November 3-6, 2024: https://medtechconf.com/event/afrisummit/
- MEDICA – November 11-14, 2024 : https://medtechconf.com/event/medica-2024/
NB
- ISS IVDR Notified Body – ISTITUTO SUPERIORE DI SANITA’: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1010586?organizationVersion=3
ROW
Middle East
- Saudi Arabia: Labelling Guidance – What should contain a Medical Device Label in Saudi Arabia: https://www.sfda.gov.sa/sites/default/files/2024-10/MDS-014En.pdf
Northern America
- USA webinar on Registation & Listing Requirements – In-Vitro Diagnostics and Laboratory Developed Tests: https://www.fda.gov/medical-devices/cdrhnew-news-and-updates/webinar-registration-listing-requirements-in-vitro-diagnostic-products-ivds-including-laboratory
- USA Guidance on Dental products – Air Powered handpiece, Dental Cements, Dental Ceramics, Impressions:
- Air powered: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/air-powered-dental-handpieces-and-air-motors-performance-criteria-safety-and-performance-based
- Dental Cements: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-cements-performance-criteria-safety-and-performance-based-pathway
- Dental Ceramics: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-ceramics-performance-criteria-safety-and-performance-based-pathway
- Dental Impressions: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-impression-materials-performance-criteria-safety-and-performance-based-pathway
- Canada policy on Drug/device combinations – Who is who?: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/policy-drug-medical-device-combination-products-decisions.html
South America:
- Brazil bans – Thermometers and Sphygmomanometers with a Mercury column: https://antigo.anvisa.gov.br/documents/10181/6873945/RDC_922_2024_.pdf/1e09cbf1-53db-4609-bea7-34afb7ce633c
PODCAST
- Podcast Nostalgia – Last podcast to listen to-
- Episode 302 – How to do PMCF literature Search for Medical Devices with Cesare Magri 4BetterDevices: https://podcast.easymedicaldevice.com/302-2/
- Episode 303 – UK vs EU vs US – How to switch to another region easily? With Claire Dyson DQS : https://podcast.easymedicaldevice.com/303-2/
- Episode 304 – How to select the best plastic for your Medical Device? Lucas Pianegonda Gradical: https://podcast.easymedicaldevice.com/305-2/
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, October 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
314 つのエピソード
シェア
Manage episode 444420129 series 2591977
コンテンツは Monir El Azzouzi によって提供されます。エピソード、グラフィック、ポッドキャストの説明を含むすべてのポッドキャスト コンテンツは、Monir El Azzouzi またはそのポッドキャスト プラットフォーム パートナーによって直接アップロードされ、提供されます。誰かがあなたの著作物をあなたの許可なく使用していると思われる場合は、ここで概説されているプロセスに従うことができますhttps://ja.player.fm/legal。
Medboard: https://www.medboard.com/
EUROPE
- TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf
- TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf
- MDCG 2021-4 Rev 1 update- Deletion, revision, addition of questions: https://health.ec.europa.eu/document/download/9f23fca0-f407-4e45-a464-2d71b575d1fe_en?filename=mdcg_2021-4_en.pdf
- Swissmedic – Deadline for Swissdamed – November 13th, 2024: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/archive/swissdamed/swissdamed-frist-13-11-24.html
- Swiss review of old legislation devices – Check that all are up-to-date: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/overview-medical-devices/aufforderung-ueberpruefung-altrechtlicher-produkte.html
- UK on their new Regulation – Restart ongoing: https://medregs.blog.gov.uk/2024/09/25/an-update-on-our-plans-for-med-tech-regulatory-change/
EVENTS
- TEAM-PRRC – October 17-18. 2024: https://medtechconf.com/event/team-prrc-third-annual-summit/
- Afrisummit – November 3-6, 2024: https://medtechconf.com/event/afrisummit/
- MEDICA – November 11-14, 2024 : https://medtechconf.com/event/medica-2024/
NB
- ISS IVDR Notified Body – ISTITUTO SUPERIORE DI SANITA’: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1010586?organizationVersion=3
ROW
Middle East
- Saudi Arabia: Labelling Guidance – What should contain a Medical Device Label in Saudi Arabia: https://www.sfda.gov.sa/sites/default/files/2024-10/MDS-014En.pdf
Northern America
- USA webinar on Registation & Listing Requirements – In-Vitro Diagnostics and Laboratory Developed Tests: https://www.fda.gov/medical-devices/cdrhnew-news-and-updates/webinar-registration-listing-requirements-in-vitro-diagnostic-products-ivds-including-laboratory
- USA Guidance on Dental products – Air Powered handpiece, Dental Cements, Dental Ceramics, Impressions:
- Air powered: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/air-powered-dental-handpieces-and-air-motors-performance-criteria-safety-and-performance-based
- Dental Cements: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-cements-performance-criteria-safety-and-performance-based-pathway
- Dental Ceramics: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-ceramics-performance-criteria-safety-and-performance-based-pathway
- Dental Impressions: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-impression-materials-performance-criteria-safety-and-performance-based-pathway
- Canada policy on Drug/device combinations – Who is who?: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/policy-drug-medical-device-combination-products-decisions.html
South America:
- Brazil bans – Thermometers and Sphygmomanometers with a Mercury column: https://antigo.anvisa.gov.br/documents/10181/6873945/RDC_922_2024_.pdf/1e09cbf1-53db-4609-bea7-34afb7ce633c
PODCAST
- Podcast Nostalgia – Last podcast to listen to-
- Episode 302 – How to do PMCF literature Search for Medical Devices with Cesare Magri 4BetterDevices: https://podcast.easymedicaldevice.com/302-2/
- Episode 303 – UK vs EU vs US – How to switch to another region easily? With Claire Dyson DQS : https://podcast.easymedicaldevice.com/303-2/
- Episode 304 – How to select the best plastic for your Medical Device? Lucas Pianegonda Gradical: https://podcast.easymedicaldevice.com/305-2/
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, October 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
314 つのエピソード
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Player FMは今からすぐに楽しめるために高品質のポッドキャストをウェブでスキャンしています。 これは最高のポッドキャストアプリで、Android、iPhone、そしてWebで動作します。 全ての端末で購読を同期するためにサインアップしてください。
Medical Device made Easy Podcastに似ているもの
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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How can business help solve society’s biggest challenges? Welcome to Series 3 of Take on Tomorrow, the award-winning podcast from PwC that examines the biggest problems facing society and the role business can—and should—play in solving them. This series, we’re welcoming broadcaster and journalist Femi Oke to the show. She joins podcaster and journalist Lizzie O’Leary, and together with industry innovators, tech trailblazers and visionary leaders from around the globe, they’ll explore timely ...
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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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