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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Innhold levert av Monir El Azzouzi. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Monir El Azzouzi eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.
Lik 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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continue reading
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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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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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Join host and Harvard Business School Online Creative Director Chris Linnane as he sits down with HBS faculty to discuss business education in a way that’s both entertaining and insightful. The Parlor Room is your key to breaking down academic theory without sacrificing depth—all while gaining practical takeaways for navigating the business world.
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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 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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Introducing The Unshakeables, a new podcast from Chase for Business and iHeartMedia's Ruby Studio. Small businesses are the heart and soul of this country, but it takes a brave individual to start and run a company of their own. From mom-and-pop coffee shops to auto-detailing garages -- no matter the type of industry you’re in, every small business owner knows that the journey is full of the unexpected. A single moment may even change the course of your business forever. Those who stand firm ...
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An independent radio station from Tel Aviv. For music lovers by music lovers.
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Medical Device News November 2024 Regulatory Update
Manage episode 447728456 series 2591977
Innhold levert av Monir El Azzouzi. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Monir El Azzouzi eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.
Medboard
EU
- Urgent update needed – EU MDR and IVDR: https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdf
- HMA communication: https://www.hma.eu/fileadmin/dateien/Medical_Devices/CGMD/241018_Letter.pdf
- EU Commission Newsletter – What are the hot news: https://ec.europa.eu/newsroom/sante/newsletter-archives/56793
- MDCG 2021-25 ;legacy devices & devices placed on the market prior to 26 May 2021: https://health.ec.europa.eu/document/download/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en?filename=md_mdcg_2021_25_en.pdf
- Notified Bodies Overview – How many still remaining: https://health.ec.europa.eu/do cument/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf
- New MDR NEOEMKI in Bulgaria: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=0e4e49a1afef458542254b3556a5e83d85321b23&group=NOTIFICATION&download=true
- HPRA Notification for In-house Manufacturers – Frequently Asked Questions: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/sur-g0053-faq-on-notification-for-in-house-manufacturers-of-medical-devices-and-in-vitro-diagnostic-medical-devices-v1.pdf?sfvrsn=8
- Harmonized Standards Summary List – For MDR and IVDR:
- MDCG 2024-11 – Qualification of IVDR: https://health.ec.europa.eu/document/download/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf
- PMS is not implemented correctly – IGJ report is shocking: https://english.igj.nl/binaries/igj-en/documenten/publication/2024/10/08/call-to-medical-device-manufacturers-implement-an-effective-pms-system/20241003_Call+to+medical+device+manufacturers+implement+effective+PMS+system.pdf
- EUDAMED in Turkey – Message: You should use it: https://titck.gov.tr/duyuru/tcokka-tibbi-cihazlara-iliskin-avrupa-veri-tabani-hakkinda-teblig-taslagina-iliskin-duyuru-11102024094328
- Turkey registration limited – 10 per individual: https://titck.gov.tr/duyuru/tibbi-cihaz-belge-ve-urun-kaydi-yapan-firma-ve-kullanicilarina-iliskin-duyuru-07102024151251
- UK Post-Market Surveillance – New amendment: https://www.legislation.gov.uk/ukdsi/2024/9780348264593/data.pdf
Training
- Team-NB training on Technical Documentation- November 6th: https://www.team-nb.org/wp-content/uploads/2024/07/Leaflet-MDR-TD-Manufacturers-Training-20241106.pdf
Events
MedtechConf events – Check the MAP
- Afrisummit 2024 in Cairo November 3 to 6: https://medtechconf.com/event/afrisummit/
- MEDxD 2024 In Berlin November 7th: https://medtechconf.com/event/medxd-medtech-meets-digital-2024/
- Medica 2024 in Dusseldorf November 11th: https://medtechconf.com/event/medica-2024/
ROW
Australia
- What is a Personalized Medical Device? – In Australia: https://www.tga.gov.au/sites/default/files/2024-10/understanding-personalised-medical-devices%20rules-including-3d-printed%20devices.pdf
- How to submit a notification on custom-made device in Australia: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf
Mexico
GMP for Mexico – Draft document: https://www.dof.gob.mx/nota_detalle.php?codigo=5734591&fecha=26/07/2024#gsc.tab=0
South Africa
- South Africa and Australia MoU – Harmonization is on the way: https://www.sahpra.org.za/news-and-updates/south-african-and-australian-health-product-regulators-to-share-regulatory-information-and-expertise/
PODCAST
Podcast Nostalgia – Let’s review
- Episode 306 – What are the TOP 3 issues on CAPA with Georg Digel: https://podcast.easymedicaldevice.com/306-2/
- Episode 307 – What does a strategy for Regulatory Compliance Look like? https://podcast.easymedicaldevice.com/307-2/
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 November 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
320 episoder
Del
Manage episode 447728456 series 2591977
Innhold levert av Monir El Azzouzi. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Monir El Azzouzi eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.
Medboard
EU
- Urgent update needed – EU MDR and IVDR: https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdf
- HMA communication: https://www.hma.eu/fileadmin/dateien/Medical_Devices/CGMD/241018_Letter.pdf
- EU Commission Newsletter – What are the hot news: https://ec.europa.eu/newsroom/sante/newsletter-archives/56793
- MDCG 2021-25 ;legacy devices & devices placed on the market prior to 26 May 2021: https://health.ec.europa.eu/document/download/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en?filename=md_mdcg_2021_25_en.pdf
- Notified Bodies Overview – How many still remaining: https://health.ec.europa.eu/do cument/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf
- New MDR NEOEMKI in Bulgaria: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=0e4e49a1afef458542254b3556a5e83d85321b23&group=NOTIFICATION&download=true
- HPRA Notification for In-house Manufacturers – Frequently Asked Questions: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/sur-g0053-faq-on-notification-for-in-house-manufacturers-of-medical-devices-and-in-vitro-diagnostic-medical-devices-v1.pdf?sfvrsn=8
- Harmonized Standards Summary List – For MDR and IVDR:
- MDCG 2024-11 – Qualification of IVDR: https://health.ec.europa.eu/document/download/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf
- PMS is not implemented correctly – IGJ report is shocking: https://english.igj.nl/binaries/igj-en/documenten/publication/2024/10/08/call-to-medical-device-manufacturers-implement-an-effective-pms-system/20241003_Call+to+medical+device+manufacturers+implement+effective+PMS+system.pdf
- EUDAMED in Turkey – Message: You should use it: https://titck.gov.tr/duyuru/tcokka-tibbi-cihazlara-iliskin-avrupa-veri-tabani-hakkinda-teblig-taslagina-iliskin-duyuru-11102024094328
- Turkey registration limited – 10 per individual: https://titck.gov.tr/duyuru/tibbi-cihaz-belge-ve-urun-kaydi-yapan-firma-ve-kullanicilarina-iliskin-duyuru-07102024151251
- UK Post-Market Surveillance – New amendment: https://www.legislation.gov.uk/ukdsi/2024/9780348264593/data.pdf
Training
- Team-NB training on Technical Documentation- November 6th: https://www.team-nb.org/wp-content/uploads/2024/07/Leaflet-MDR-TD-Manufacturers-Training-20241106.pdf
Events
MedtechConf events – Check the MAP
- Afrisummit 2024 in Cairo November 3 to 6: https://medtechconf.com/event/afrisummit/
- MEDxD 2024 In Berlin November 7th: https://medtechconf.com/event/medxd-medtech-meets-digital-2024/
- Medica 2024 in Dusseldorf November 11th: https://medtechconf.com/event/medica-2024/
ROW
Australia
- What is a Personalized Medical Device? – In Australia: https://www.tga.gov.au/sites/default/files/2024-10/understanding-personalised-medical-devices%20rules-including-3d-printed%20devices.pdf
- How to submit a notification on custom-made device in Australia: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf
Mexico
GMP for Mexico – Draft document: https://www.dof.gob.mx/nota_detalle.php?codigo=5734591&fecha=26/07/2024#gsc.tab=0
South Africa
- South Africa and Australia MoU – Harmonization is on the way: https://www.sahpra.org.za/news-and-updates/south-african-and-australian-health-product-regulators-to-share-regulatory-information-and-expertise/
PODCAST
Podcast Nostalgia – Let’s review
- Episode 306 – What are the TOP 3 issues on CAPA with Georg Digel: https://podcast.easymedicaldevice.com/306-2/
- Episode 307 – What does a strategy for Regulatory Compliance Look like? https://podcast.easymedicaldevice.com/307-2/
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 November 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
320 episoder
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Lik Medical Device made Easy Podcast
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
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
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
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
Join host and Harvard Business School Online Creative Director Chris Linnane as he sits down with HBS faculty to discuss business education in a way that’s both entertaining and insightful. The Parlor Room is your key to breaking down academic theory without sacrificing depth—all while gaining practical takeaways for navigating the business world.
…
continue reading
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 ...
…
continue reading
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
Business tips for startups by proven entrepreneurs
…
continue reading
Introducing The Unshakeables, a new podcast from Chase for Business and iHeartMedia's Ruby Studio. Small businesses are the heart and soul of this country, but it takes a brave individual to start and run a company of their own. From mom-and-pop coffee shops to auto-detailing garages -- no matter the type of industry you’re in, every small business owner knows that the journey is full of the unexpected. A single moment may even change the course of your business forever. Those who stand firm ...
…
continue reading
An independent radio station from Tel Aviv. For music lovers by music lovers.
…
continue reading
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