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
Contenuto fornito da Monir El Azzouzi. Tutti i contenuti dei podcast, inclusi episodi, grafica e descrizioni dei podcast, vengono caricati e forniti direttamente da Monir El Azzouzi o dal partner della piattaforma podcast. Se ritieni che qualcuno stia utilizzando la tua opera protetta da copyright senza la tua autorizzazione, puoi seguire la procedura descritta qui https://it.player.fm/legal.
Simile a Medical Device made Easy Podcast
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
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
…
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
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
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 ...
…
continue reading
Custom Manufacturing Industry podcast is an entrepreneurship and motivational podcast on all platforms, hosted by Aaron Clippinger. Being CEO of multiple companies including the signage industry and the software industry, Aaron has over 20 years of consulting and business management. His software has grown internationally and with over a billion dollars annually going through the software. Using his Accounting degree, Aaron will be talking about his organizational ways to get things done. Hi ...
…
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
Outsource Acelerator Podcast, hosted by Derek Gallimore, explores business and outsourcing mastery. Inside-knowledge from the outsourcing capital of the world - Manila, Philippines.
…
continue reading
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 ...
…
continue reading
Player FM - App Podcast
Vai offline con l'app Player FM !
Vai offline con l'app Player FM !
))
Medical Device NewsMAY 2024 Regulatory Update
Manage episode 415972307 series 2591977
Contenuto fornito da Monir El Azzouzi. Tutti i contenuti dei podcast, inclusi episodi, grafica e descrizioni dei podcast, vengono caricati e forniti direttamente da Monir El Azzouzi o dal partner della piattaforma podcast. Se ritieni che qualcuno stia utilizzando la tua opera protetta da copyright senza la tua autorizzazione, puoi seguire la procedura descritta qui https://it.player.fm/legal.
EU
- Notified Bodies
- TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true
- AFNOR 46th NB under MDR –Finally a second one for France: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43655&filter=notificationStatusId:1
- MDCG 2024-4 Guidance–Safety reporting in Performance Studies or IVD: https://health.ec.europa.eu/document/download/5cc894e0-331d-4fa2-8ab3-cdd4437c48fc_en?filename=mdcg_2024-4_en.pdf
- MDCG 2024-5 Guidance – SInvestigator’s Brochure for Clinical Investigation: https://health.ec.europa.eu/document/download/ee7ee8eb-841a-4085-a8dc-af6d55ebf1bd_en?filename=mdcg_2024-5_en.pdf
- Survey Article 17 – Reprocessing of single use devices: https://op.europa.eu/o/opportal-service/download-handler?identifier=35ea0c60-e82c-11ee-9ea8-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=
- Team-NB: ESMINT initiative – Call for expert: https://www.team-nb.org/esmint-initiative/
- Spain AEMPS Bulletin on Health Products – From Jan – March 2024: https://www.aemps.gob.es/informa/boletin-sobre-productos-sanitarios-enero-marzo-de-2024/#vigProdSan
- Germany: Classification – Bfarm to help you classify your device: https://www.bfarm.de/DE/Medizinprodukte/Antraege-und-Meldungen/Antrag-auf-Klassifizierung/_artikel.html
- Swiss: SaMD – information sheet to help Software companies: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_007d_mbmedizinprodukte-software.pdf.download.pdf/BW630_30_007e_MB%20Medical%20Device%20Software.pdf
- Turkey: 26 May 2024 – Reminder of the May 26th, 2024 deadline for EU MDR https://titck.gov.tr/duyuru/imalatcisi-tarafindan-sure-uzatimindan-faydalanmayacak-urunlerin-uts-surecleri-24042024160706
Article to read
- European Medical Writers Association – Focus on Translation: https://journal.emwa.org/media/5111/mew-331-final.pdf
Training
- Training EU MDR – Green Belt Certification Program GB31 May 2024: https://school.easymedicaldevice.com/course/gb31/
- Malaysia training – Calendar 2024: https://portal.mda.gov.my/index.php/doclink/mda-core-training-list-2024-latest-nur-izzati-adha-binti-zuman-mda-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJtZGEtY29yZS10cmFpbmluZy1saXN0LTIwMjQtbGF0ZXN0LW51ci1penphdGktYWRoYS1iaW50aS16dW1hbi1tZGEtcGRmIiwiaWF0IjoxNzE0MDEwNjUyLCJleHAiOjE3MTQwOTcwNTJ9.1KCY_1RCNi1mnJSCP30llN8kaBvcBJU6G_JMpc-OttI
- Team-NB training – IVDR technical Documentation July 3rd, 2024: https://www.team-nb.org/fourth-session-ivdr-technical-documentation-training-for-manufacturers/
Events
- Events – Check Medtech Conf: https://MedtechConf.com
Rest of the world
- South Korea: Certificate Check –Verifying authenticity of certificates issued by MDFS: https://emedi.mfds.go.kr/msismext/emd/uif/issuDocTruflsEngView.do
- South Korea: IVD method –How to register IVD in South Korea: https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%B2%B4%EC%99%B8%EC%A7%84%EB%8B%A8%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0%EB%B2%95/(19695,20230816)
- South Korea: UDI rules to follow –Same but not the same: https://www.mfds.go.kr/eng/brd/m_40/down.do?brd_id=eng0011&seq=72636&data_tp=A&file_seq=1
Mexico: Draft Mexican official standard –Labelling of Medical Devices: https://www.dof.gob.mx/nota_detalle.php?codigo=5724246&fecha=23/04/2024#gsc.tab=0
- Australia: Consultation on IFU – Call for more flexibility: https://www.tga.gov.au/resources/consultation/consultation-availability-instructions-use-ifu-more-flexible-formats
Podcast
- Radiation Sterilisation Master File – Adam Issacs Rae: https://podcast.easymedicaldevice.com/279-2/
- What is the impact of AI Act on Medical Devices – Erik Vollebregt: https://podcast.easymedicaldevice.com/280-2/
- Why and how to build your Quality Culture – Lesley Worthington: https://podcast.easymedicaldevice.com/281-2/
The post Medical Device NewsMAY 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
297 episodi
Condividi
Manage episode 415972307 series 2591977
Contenuto fornito da Monir El Azzouzi. Tutti i contenuti dei podcast, inclusi episodi, grafica e descrizioni dei podcast, vengono caricati e forniti direttamente da Monir El Azzouzi o dal partner della piattaforma podcast. Se ritieni che qualcuno stia utilizzando la tua opera protetta da copyright senza la tua autorizzazione, puoi seguire la procedura descritta qui https://it.player.fm/legal.
EU
- Notified Bodies
- TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true
- AFNOR 46th NB under MDR –Finally a second one for France: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43655&filter=notificationStatusId:1
- MDCG 2024-4 Guidance–Safety reporting in Performance Studies or IVD: https://health.ec.europa.eu/document/download/5cc894e0-331d-4fa2-8ab3-cdd4437c48fc_en?filename=mdcg_2024-4_en.pdf
- MDCG 2024-5 Guidance – SInvestigator’s Brochure for Clinical Investigation: https://health.ec.europa.eu/document/download/ee7ee8eb-841a-4085-a8dc-af6d55ebf1bd_en?filename=mdcg_2024-5_en.pdf
- Survey Article 17 – Reprocessing of single use devices: https://op.europa.eu/o/opportal-service/download-handler?identifier=35ea0c60-e82c-11ee-9ea8-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=
- Team-NB: ESMINT initiative – Call for expert: https://www.team-nb.org/esmint-initiative/
- Spain AEMPS Bulletin on Health Products – From Jan – March 2024: https://www.aemps.gob.es/informa/boletin-sobre-productos-sanitarios-enero-marzo-de-2024/#vigProdSan
- Germany: Classification – Bfarm to help you classify your device: https://www.bfarm.de/DE/Medizinprodukte/Antraege-und-Meldungen/Antrag-auf-Klassifizierung/_artikel.html
- Swiss: SaMD – information sheet to help Software companies: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_007d_mbmedizinprodukte-software.pdf.download.pdf/BW630_30_007e_MB%20Medical%20Device%20Software.pdf
- Turkey: 26 May 2024 – Reminder of the May 26th, 2024 deadline for EU MDR https://titck.gov.tr/duyuru/imalatcisi-tarafindan-sure-uzatimindan-faydalanmayacak-urunlerin-uts-surecleri-24042024160706
Article to read
- European Medical Writers Association – Focus on Translation: https://journal.emwa.org/media/5111/mew-331-final.pdf
Training
- Training EU MDR – Green Belt Certification Program GB31 May 2024: https://school.easymedicaldevice.com/course/gb31/
- Malaysia training – Calendar 2024: https://portal.mda.gov.my/index.php/doclink/mda-core-training-list-2024-latest-nur-izzati-adha-binti-zuman-mda-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJtZGEtY29yZS10cmFpbmluZy1saXN0LTIwMjQtbGF0ZXN0LW51ci1penphdGktYWRoYS1iaW50aS16dW1hbi1tZGEtcGRmIiwiaWF0IjoxNzE0MDEwNjUyLCJleHAiOjE3MTQwOTcwNTJ9.1KCY_1RCNi1mnJSCP30llN8kaBvcBJU6G_JMpc-OttI
- Team-NB training – IVDR technical Documentation July 3rd, 2024: https://www.team-nb.org/fourth-session-ivdr-technical-documentation-training-for-manufacturers/
Events
- Events – Check Medtech Conf: https://MedtechConf.com
Rest of the world
- South Korea: Certificate Check –Verifying authenticity of certificates issued by MDFS: https://emedi.mfds.go.kr/msismext/emd/uif/issuDocTruflsEngView.do
- South Korea: IVD method –How to register IVD in South Korea: https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%B2%B4%EC%99%B8%EC%A7%84%EB%8B%A8%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0%EB%B2%95/(19695,20230816)
- South Korea: UDI rules to follow –Same but not the same: https://www.mfds.go.kr/eng/brd/m_40/down.do?brd_id=eng0011&seq=72636&data_tp=A&file_seq=1
Mexico: Draft Mexican official standard –Labelling of Medical Devices: https://www.dof.gob.mx/nota_detalle.php?codigo=5724246&fecha=23/04/2024#gsc.tab=0
- Australia: Consultation on IFU – Call for more flexibility: https://www.tga.gov.au/resources/consultation/consultation-availability-instructions-use-ifu-more-flexible-formats
Podcast
- Radiation Sterilisation Master File – Adam Issacs Rae: https://podcast.easymedicaldevice.com/279-2/
- What is the impact of AI Act on Medical Devices – Erik Vollebregt: https://podcast.easymedicaldevice.com/280-2/
- Why and how to build your Quality Culture – Lesley Worthington: https://podcast.easymedicaldevice.com/281-2/
The post Medical Device NewsMAY 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
297 episodi
Tutti gli episodi
×
Benvenuto su Player FM!
Player FM ricerca sul web podcast di alta qualità che tu possa goderti adesso. È la migliore app di podcast e funziona su Android, iPhone e web. Registrati per sincronizzare le iscrizioni su tutti i tuoi dispositivi.
Simile a Medical Device made Easy Podcast
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
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
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
…
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
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
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 ...
…
continue reading
Custom Manufacturing Industry podcast is an entrepreneurship and motivational podcast on all platforms, hosted by Aaron Clippinger. Being CEO of multiple companies including the signage industry and the software industry, Aaron has over 20 years of consulting and business management. His software has grown internationally and with over a billion dollars annually going through the software. Using his Accounting degree, Aaron will be talking about his organizational ways to get things done. Hi ...
…
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
Outsource Acelerator Podcast, hosted by Derek Gallimore, explores business and outsourcing mastery. Inside-knowledge from the outsourcing capital of the world - Manila, Philippines.
…
continue reading
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 ...
…
continue reading
Player FM - App Podcast
Vai offline con l'app Player FM !
Vai offline con l'app Player FM !
