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Medical Device News – July 2023 Regulatory Update
MP3•Episoder hjem
Manage episode 367831488 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.
- Sponsor Medboard https://www.medboard.com/
EU
- Annex XVI transition https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1194
- Cybersecurity and privacy in AI https://www.enisa.europa.eu/publications/cybersecurity-and-privacy-in-ai-medical-imaging-diagnosis
- ANSM wants barcode on Field Safety Notice https://ansm.sante.fr/actualites/lansm-demande-aux-fabricants-de-dispositifs-medicaux-qui-envoient-un-avis-de-securite-dy-apposer-le-code-barres-des-dispositifs-concernes
- AEMPS clinical trials involving drugs and medical devices https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-procedimiento-a-seguir-en-los-ensayos-clinicos-que-impliquen-medicamentos-y-productos-sanitarios/
Switzerland
- Medicinal products with a medical device component https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/am-mit-mepkomponente-uebergangsbestimmungen.html
UK
- Implementation of the Future Regulations https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations
eQMS
- Do you need an eQMS? https://smart-eye.io
- So contact info@scube-technologies.com to get a demo
USA
- Premarket notification for Software https://www.fda.gov/media/153781/download
- Webinar – Final Guidance: Content of Premarket Submissions for Device Software Functions https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-content-premarket-submissions-device-software-functions-07202023
Australia
- TGA Use of market authorization evidence https://www.tga.gov.au/resources/resource/guidance/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds
Malaysia
- Malaysia rules on EU MDR extension https://www.mda.gov.my/announcement/1224-announcement-mda-approach-on-expired-ec-certificate-for-new-registration-and-re-registration-of-medical-device.html
Saudi Arabia
- Saudi Arabia Webinars
- Artificial Intelligence and Software Based on Medical Device https://www.sfda.gov.sa/en/workshop/88535
- Introducing the Rules for Classifying the Risk of Medical Devices https://www.sfda.gov.sa/en/workshop/88536
Authorized Representative
- Europe. https://easymedicaldevice.com/eu-rep/
- UK: https://easymedicaldevice.com/uk-responsible-person/
- Switzerland: https://easymedicaldevice.com/swiss-authorised-representative/
Podcast Nostalgia:
- The great Misunderstanding with Florian Tolkmitt: https://podcast.easymedicaldevice.com/236-2/
- How to connect Software dev and QARA team with Christophe Girargey Wega: https://podcast.easymedicaldevice.com/237-2/
- What should you know on the UKCA extension with Alex Denoon: https://podcast.easymedicaldevice.com/238-2/
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
- Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
- Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424
The post Medical Device News – July 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
293 episoder
MP3•Episoder hjem
Manage episode 367831488 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.
- Sponsor Medboard https://www.medboard.com/
EU
- Annex XVI transition https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1194
- Cybersecurity and privacy in AI https://www.enisa.europa.eu/publications/cybersecurity-and-privacy-in-ai-medical-imaging-diagnosis
- ANSM wants barcode on Field Safety Notice https://ansm.sante.fr/actualites/lansm-demande-aux-fabricants-de-dispositifs-medicaux-qui-envoient-un-avis-de-securite-dy-apposer-le-code-barres-des-dispositifs-concernes
- AEMPS clinical trials involving drugs and medical devices https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-procedimiento-a-seguir-en-los-ensayos-clinicos-que-impliquen-medicamentos-y-productos-sanitarios/
Switzerland
- Medicinal products with a medical device component https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/am-mit-mepkomponente-uebergangsbestimmungen.html
UK
- Implementation of the Future Regulations https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations
eQMS
- Do you need an eQMS? https://smart-eye.io
- So contact info@scube-technologies.com to get a demo
USA
- Premarket notification for Software https://www.fda.gov/media/153781/download
- Webinar – Final Guidance: Content of Premarket Submissions for Device Software Functions https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-content-premarket-submissions-device-software-functions-07202023
Australia
- TGA Use of market authorization evidence https://www.tga.gov.au/resources/resource/guidance/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds
Malaysia
- Malaysia rules on EU MDR extension https://www.mda.gov.my/announcement/1224-announcement-mda-approach-on-expired-ec-certificate-for-new-registration-and-re-registration-of-medical-device.html
Saudi Arabia
- Saudi Arabia Webinars
- Artificial Intelligence and Software Based on Medical Device https://www.sfda.gov.sa/en/workshop/88535
- Introducing the Rules for Classifying the Risk of Medical Devices https://www.sfda.gov.sa/en/workshop/88536
Authorized Representative
- Europe. https://easymedicaldevice.com/eu-rep/
- UK: https://easymedicaldevice.com/uk-responsible-person/
- Switzerland: https://easymedicaldevice.com/swiss-authorised-representative/
Podcast Nostalgia:
- The great Misunderstanding with Florian Tolkmitt: https://podcast.easymedicaldevice.com/236-2/
- How to connect Software dev and QARA team with Christophe Girargey Wega: https://podcast.easymedicaldevice.com/237-2/
- What should you know on the UKCA extension with Alex Denoon: https://podcast.easymedicaldevice.com/238-2/
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
- Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/
- Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424
The post Medical Device News – July 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir
293 episoder
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