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
Вміст надано Monir El Azzouzi. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією Monir El Azzouzi або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.
Схожі до 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
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
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
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 - додаток Podcast
Переходьте в офлайн за допомогою програми Player FM !
Переходьте в офлайн за допомогою програми Player FM !
))
Medical Device News June 2024 Regulatory Update
Manage episode 422947339 series 2591977
Вміст надано Monir El Azzouzi. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією Monir El Azzouzi або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.
- EUROPE
- EU MDR 26 May 2024 – Was there any apocalypse:
- France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-la-periode-de-transition
- Netherland: https://www.igj.nl/zorgsectoren/medische-technologie/nieuws/2024/05/23/fabrikanten-van-medische-hulpmiddelen-moeten-uiterlijk-26-mei-een-aanvraag-hebben-ingediend-voor-ce-certificering
- EU shortage managed – EUDAMED and IVD extension also discussed: https://www.consilium.europa.eu/en/press/press-releases/2024/05/30/medical-devices-council-adopts-new-measures-to-help-prevent-shortages/?utm_source=brevo&utm_campaign=AUTOMATED%20-%20Alert%20-%20Newsletter&utm_medium=email&utm_id=320
- EMA Q&A on Combination products – Do you need a Notified Body? https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf
- EU talks about SoHo -: Substances of Human Origin
- Italy Database error – Updating expired (AI)MDD certificates https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6569
- Ireland guide on In-House IVDs – Laboratories to listen: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-for-health-institutions-who-manufacture-and-use-in-house-ivds-in-ireland-v1.pdf?sfvrsn=8
- Combined Studies in the EU – COMBINE PROJECT:
- EU MDR 26 May 2024 – Was there any apocalypse:
- Notified Bodies
- Survey Result: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf
- Team-NB Survey: https://www.team-nb.org/wp-content/uploads/2024/05/Team-NB-MD-Sector-Survey-PressRelease-20240515.pdf
- New Notified Bodies for EU MDR –
- MTIC InterCert Italy: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43390&filter=notificationStatusId:1
- Kiwa Istanbul: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007731?organizationVersion=18
- QMS Services GmbH Austria: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007832?organizationVersion=1
- UK
- UK on international recognition – Approve products without CE or UKCA mark:
- UK implementation of Future Regulation – When will this come in force: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations
- UK Common Specifications for IVD – Provide your opinion: https://www.gov.uk/government/consultations/common-specification-requirements-for-in-vitro-diagnostic-devices
- UK suspected counterfeit Medical Device – How to report: https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/report-a-non-compliant-or-suspected-counterfeit-medical-device
- UK Ai Airlock – Be ready to help the government: https://www.gov.uk/government/news/mhra-launches-ai-airlock-to-address-challenges-for-regulating-medical-devices-that-use-artificial-intelligence
- Easy Medical Device: eQMS SmartEye
- Events:
- Medtech Conf:
- Title: International Medical Device Exhibition and Conference – Subtitle: Malaysia 10th to 12th December 2024 : https://medtechconf.com/event/imdec-2024-exhibition-conference/
- Medtech Conf:
- Training
- Green Belt Training for EU MDR 2017/745 24th-28th June 2024: https://school.easymedicaldevice.com/gb/
- EU Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
- Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
- WORLD
- US
- US Remanufacturing or Servicing – Webinar replay included:
- US – Use of Patient Generated Data – Medical Device Development: https://www.fda.gov/medical-devices/medical-devices-news-and-events/co-sponsored-public-workshop-using-patient-generated-health-data-medical-device-development-case
- US Laboratory Developed Tests – Final rules defined and Webinar to explain:
- https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-rule-medical-devices-laboratory-developed-tests-05142024
- https://www.fda.gov/medical-devices/laboratory-developed-tests/laboratory-developed-tests-frequently-asked-questions
- https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests
- Australia
- Australia – in-house IVDs requirements – Support Australian Laboratories: https://www.tga.gov.au/resources/resource/guidance/regulatory-requirements-house-ivds
- Australia on boundary and Combination products List: https://www.tga.gov.au/sites/default/files/2024-05/examples-boundary-combination-products-and-product-category.pdf
- Saudi Arabia
- Saudi Arabia – Webinar Biological Evaluation – 6 June 2024 10am Saudi Time https://www.sfda.gov.sa/en/workshop/716404
- Nigeria
- Guidance to register Medical Devices – Registration, labelling and advertising:
- https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Registration-Regulations-2024.pdf
- https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Labelling-Regulations-2024.pdf
- https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Advertisement-Regulations-2024.pdf
- Guidance to register Medical Devices – Registration, labelling and advertising:
- India
- CDSCO laboratory testing – But in the Country and not outside: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEzMTg=
- Malaysia
- Malaysia Guidance for Medical Device – Change Notification support: https://www.mda.gov.my/index.php/announcement/1401-public-comment-draft-guidance-document-change-notification-for-registered-medical-device
- Hong-Kong
- Overview of a Local Responsible Person – Who? What? When? Where?: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf
- Singapore
- Singapore Cybersecurity labelling- SAt which level is your product: https://www.csa.gov.sg/our-programmes/certification-and-labelling-schemes/cls-md
- US
- PODCAST
- Podcast Nostalgia – What topics were discussed
- Episode 283: Quality Field Service for Medical Devices with Michael Israel: https://podcast.easymedicaldevice.com/283-2/
- Episode 284: How to select and evaluate your Contract Manufacturer with Keith Smith: https://podcast.easymedicaldevice.com/284-2/
- Episode 285: Are you Correction or Corrective Action or Preventive Action with Vincent Cafiso: https://podcast.easymedicaldevice.com/285-2/
- Episode 286: Summative Evaluation – Common Mistakes with Amandine Broussier: https://podcast.easymedicaldevice.com/286-2/
- Podcast Nostalgia – What topics were discussed
The post Medical Device News June 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
299 епізодів
Поширити
Manage episode 422947339 series 2591977
Вміст надано Monir El Azzouzi. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією Monir El Azzouzi або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.
- EUROPE
- EU MDR 26 May 2024 – Was there any apocalypse:
- France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-la-periode-de-transition
- Netherland: https://www.igj.nl/zorgsectoren/medische-technologie/nieuws/2024/05/23/fabrikanten-van-medische-hulpmiddelen-moeten-uiterlijk-26-mei-een-aanvraag-hebben-ingediend-voor-ce-certificering
- EU shortage managed – EUDAMED and IVD extension also discussed: https://www.consilium.europa.eu/en/press/press-releases/2024/05/30/medical-devices-council-adopts-new-measures-to-help-prevent-shortages/?utm_source=brevo&utm_campaign=AUTOMATED%20-%20Alert%20-%20Newsletter&utm_medium=email&utm_id=320
- EMA Q&A on Combination products – Do you need a Notified Body? https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf
- EU talks about SoHo -: Substances of Human Origin
- Italy Database error – Updating expired (AI)MDD certificates https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6569
- Ireland guide on In-House IVDs – Laboratories to listen: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-for-health-institutions-who-manufacture-and-use-in-house-ivds-in-ireland-v1.pdf?sfvrsn=8
- Combined Studies in the EU – COMBINE PROJECT:
- EU MDR 26 May 2024 – Was there any apocalypse:
- Notified Bodies
- Survey Result: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf
- Team-NB Survey: https://www.team-nb.org/wp-content/uploads/2024/05/Team-NB-MD-Sector-Survey-PressRelease-20240515.pdf
- New Notified Bodies for EU MDR –
- MTIC InterCert Italy: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43390&filter=notificationStatusId:1
- Kiwa Istanbul: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007731?organizationVersion=18
- QMS Services GmbH Austria: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007832?organizationVersion=1
- UK
- UK on international recognition – Approve products without CE or UKCA mark:
- UK implementation of Future Regulation – When will this come in force: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations
- UK Common Specifications for IVD – Provide your opinion: https://www.gov.uk/government/consultations/common-specification-requirements-for-in-vitro-diagnostic-devices
- UK suspected counterfeit Medical Device – How to report: https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/report-a-non-compliant-or-suspected-counterfeit-medical-device
- UK Ai Airlock – Be ready to help the government: https://www.gov.uk/government/news/mhra-launches-ai-airlock-to-address-challenges-for-regulating-medical-devices-that-use-artificial-intelligence
- Easy Medical Device: eQMS SmartEye
- Events:
- Medtech Conf:
- Title: International Medical Device Exhibition and Conference – Subtitle: Malaysia 10th to 12th December 2024 : https://medtechconf.com/event/imdec-2024-exhibition-conference/
- Medtech Conf:
- Training
- Green Belt Training for EU MDR 2017/745 24th-28th June 2024: https://school.easymedicaldevice.com/gb/
- EU Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/
- Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/
- WORLD
- US
- US Remanufacturing or Servicing – Webinar replay included:
- US – Use of Patient Generated Data – Medical Device Development: https://www.fda.gov/medical-devices/medical-devices-news-and-events/co-sponsored-public-workshop-using-patient-generated-health-data-medical-device-development-case
- US Laboratory Developed Tests – Final rules defined and Webinar to explain:
- https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-rule-medical-devices-laboratory-developed-tests-05142024
- https://www.fda.gov/medical-devices/laboratory-developed-tests/laboratory-developed-tests-frequently-asked-questions
- https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests
- Australia
- Australia – in-house IVDs requirements – Support Australian Laboratories: https://www.tga.gov.au/resources/resource/guidance/regulatory-requirements-house-ivds
- Australia on boundary and Combination products List: https://www.tga.gov.au/sites/default/files/2024-05/examples-boundary-combination-products-and-product-category.pdf
- Saudi Arabia
- Saudi Arabia – Webinar Biological Evaluation – 6 June 2024 10am Saudi Time https://www.sfda.gov.sa/en/workshop/716404
- Nigeria
- Guidance to register Medical Devices – Registration, labelling and advertising:
- https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Registration-Regulations-2024.pdf
- https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Labelling-Regulations-2024.pdf
- https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Advertisement-Regulations-2024.pdf
- Guidance to register Medical Devices – Registration, labelling and advertising:
- India
- CDSCO laboratory testing – But in the Country and not outside: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEzMTg=
- Malaysia
- Malaysia Guidance for Medical Device – Change Notification support: https://www.mda.gov.my/index.php/announcement/1401-public-comment-draft-guidance-document-change-notification-for-registered-medical-device
- Hong-Kong
- Overview of a Local Responsible Person – Who? What? When? Where?: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf
- Singapore
- Singapore Cybersecurity labelling- SAt which level is your product: https://www.csa.gov.sg/our-programmes/certification-and-labelling-schemes/cls-md
- US
- PODCAST
- Podcast Nostalgia – What topics were discussed
- Episode 283: Quality Field Service for Medical Devices with Michael Israel: https://podcast.easymedicaldevice.com/283-2/
- Episode 284: How to select and evaluate your Contract Manufacturer with Keith Smith: https://podcast.easymedicaldevice.com/284-2/
- Episode 285: Are you Correction or Corrective Action or Preventive Action with Vincent Cafiso: https://podcast.easymedicaldevice.com/285-2/
- Episode 286: Summative Evaluation – Common Mistakes with Amandine Broussier: https://podcast.easymedicaldevice.com/286-2/
- Podcast Nostalgia – What topics were discussed
The post Medical Device News June 2024 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
299 епізодів
すべてのエピソード
×
Ласкаво просимо до Player FM!
Player FM сканує Інтернет для отримання високоякісних подкастів, щоб ви могли насолоджуватися ними зараз. Це найкращий додаток для подкастів, який працює на Android, iPhone і веб-сторінці. Реєстрація для синхронізації підписок між пристроями.
Схожі до 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
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
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
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
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 - додаток Podcast
Переходьте в офлайн за допомогою програми Player FM !
Переходьте в офлайн за допомогою програми Player FM !
