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Medical Device News: December 2021 Regulatory Update
MP3•Jakson koti
Manage episode 311576036 series 2591977
Sisällön tarjoaa Monir El Azzouzi. Monir El Azzouzi tai sen podcast-alustan kumppani lataa ja toimittaa kaiken podcast-sisällön, mukaan lukien jaksot, grafiikat ja podcast-kuvaukset. Jos uskot jonkun käyttävän tekijänoikeudella suojattua teostasi ilman lupaasi, voit seurata tässä https://fi.player.fm/legal kuvattua prosessia.
- EUDAMED
- Commission implementing regulation 2021/2078: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2078
- EUDAMED webpage: https://ec.europa.eu/health/md_eudamed/udi_devices_registration_en
- EUDAMED Playground: https://webgate.training.ec.europa.eu/eudamed-play/landing-page#/
- UDI/Devices guidance: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed_udi-devices-user-guide_en.pdf
- Infographic EUDAMED: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-concept_en.pdf
- Categorization of devices: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-devices_en.pdf
- Registration process: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-registration-process_en.pdf
- IVDR expert panel
- View in the context of the Performance Evaluation Consultation Procedure (PECP): https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000002-view_en.pdf
- Following MDCG 2021-22 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-22_en.pdf
- EU Reference laboratories (EURL)
- Feedback on Draft implementing regulation open until December 17th, 2021: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13272-EURL-fees_en
- Germany: Contact Persons for Medical Devices https://www.bfarm.de/EN/Medical-devices/Contact-persons/_artikel.html?nn=968830
- Ireland – HPRA: In-house Manufacturing of in vitro diagnostic medical devices – Survey
- Ireland – HPRA: Update on the creation of Free Sale Certificate in Ireland: http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/applying-for-a-certificate-of-free-sale-updated-information&id=d4731026-9782-6eee-9b55-ff00008c97d0
- Annex XVI products – Finland – FIMEA
- CHRISTMAS BREAK
- MHRA Christmas period: Clinical Investigation: https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device
- Belgium – FAMHP – Christmas period https://www.famhp.be/en/news/deadlines_for_the_submission_of_dossiers_during_end_of_year_period
- Switzerland: Registration of Economic Operators: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.html
- CH-RN Database: https://opendata.swiss/en/dataset/mep401-chnr-actors
- How to obtain the CHRN: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_11_001defi_fo-registrierungsantrag-einmalige-idnr-art55-mepv.pdf.download.pdf/BW630_11_001defi_FO_Antrag_Registrierung_CHRN.pdf
- Switzerland – Procurement: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/beschaffung.html
- UK MHRA: Review launched into the health impact of potential bias in medical devices : https://www.gov.uk/government/news/review-launched-into-the-health-impact-of-potential-bias-in-medical-devices
- WORLD
- USA: Final rule for Medical Device De Novo Classification Process
- Podcast episode 43 – How to register a Medical Device with FDA? (510k, PMA, DeNovo) How to register a Medical Device with FDA? (510k, PMA, de Novo…)
- USA: Draft Guidance 510K Device Software function SaMD
- Webinar Dec 16th, 2021 – Draft Guidance: Content of Premarket Submission for Device Software functions: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-draft-guidance-content-premarket-submissions-device-software-functions-12162021-12162021
- Draft guidance: https://www.fda.gov/media/153781/download
- USA: Voluntary eSTAR Program: https://www.fda.gov/medical-devices/premarket-notification-510k/voluntary-estar-program
- Non-in vitro diagnostic eStar Version 1: https://www.fda.gov/media/154429/download
- In Vitro Diagnostic eStar Version 1: https://www.fda.gov/media/154430/download
- Saudi Arabia: Borderline products https://www.sfda.gov.sa/sites/default/files/2021-11/GuidanceBorderlineProductsClassificationE.pdf
- USA: Final rule for Medical Device De Novo Classification Process
- Notified Body
- SGS Belgium: https://www.sgs.com/en/news/2021/11/sgs-belgium-nv-confirmed-as-a-notified-body-for-the-new-eu-medical-device-regulation-mdr
- MDR 25: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
- IVDR 2017/746 6: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35
- EMD
- Podcast
- Episode 153 – How to improve your QA RA Communication with Lesley Worthington: https://podcast.easymedicaldevice.com/153/
- Episode 154 – Is it possible to Private Label a Medical Device under MDR and IVDR with Erik Vollebregt: https://podcast.easymedicaldevice.com/154/
- Episode 155 – How to approach your Notified Bodies? With Dr Royth von Hahn https://podcast.easymedicaldevice.com/155/
- Episode 156 – Unleashing “MDR Classification surprises with Franck Matzek https://podcast.easymedicaldevice.com/156/
- LinkedIn Live
- Talk Cybersecurity during MDR audit with Stefan Bolleininger: https://www.youtube.com/watch?v=IK0DiXnISKE&t=4s
- IVDR 2017/746 – in-house devices: https://www.youtube.com/watch?v=AbwaA7DpbYI
- Podcast
The post Medical Device News: December 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
289 jaksoa
MP3•Jakson koti
Manage episode 311576036 series 2591977
Sisällön tarjoaa Monir El Azzouzi. Monir El Azzouzi tai sen podcast-alustan kumppani lataa ja toimittaa kaiken podcast-sisällön, mukaan lukien jaksot, grafiikat ja podcast-kuvaukset. Jos uskot jonkun käyttävän tekijänoikeudella suojattua teostasi ilman lupaasi, voit seurata tässä https://fi.player.fm/legal kuvattua prosessia.
- EUDAMED
- Commission implementing regulation 2021/2078: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2078
- EUDAMED webpage: https://ec.europa.eu/health/md_eudamed/udi_devices_registration_en
- EUDAMED Playground: https://webgate.training.ec.europa.eu/eudamed-play/landing-page#/
- UDI/Devices guidance: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed_udi-devices-user-guide_en.pdf
- Infographic EUDAMED: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-concept_en.pdf
- Categorization of devices: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-devices_en.pdf
- Registration process: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed-udi-registration-process_en.pdf
- IVDR expert panel
- View in the context of the Performance Evaluation Consultation Procedure (PECP): https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/pecp-ivd-2021-000002-view_en.pdf
- Following MDCG 2021-22 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-22_en.pdf
- EU Reference laboratories (EURL)
- Feedback on Draft implementing regulation open until December 17th, 2021: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13272-EURL-fees_en
- Germany: Contact Persons for Medical Devices https://www.bfarm.de/EN/Medical-devices/Contact-persons/_artikel.html?nn=968830
- Ireland – HPRA: In-house Manufacturing of in vitro diagnostic medical devices – Survey
- Ireland – HPRA: Update on the creation of Free Sale Certificate in Ireland: http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/applying-for-a-certificate-of-free-sale-updated-information&id=d4731026-9782-6eee-9b55-ff00008c97d0
- Annex XVI products – Finland – FIMEA
- CHRISTMAS BREAK
- MHRA Christmas period: Clinical Investigation: https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device
- Belgium – FAMHP – Christmas period https://www.famhp.be/en/news/deadlines_for_the_submission_of_dossiers_during_end_of_year_period
- Switzerland: Registration of Economic Operators: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.html
- CH-RN Database: https://opendata.swiss/en/dataset/mep401-chnr-actors
- How to obtain the CHRN: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_11_001defi_fo-registrierungsantrag-einmalige-idnr-art55-mepv.pdf.download.pdf/BW630_11_001defi_FO_Antrag_Registrierung_CHRN.pdf
- Switzerland – Procurement: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/beschaffung.html
- UK MHRA: Review launched into the health impact of potential bias in medical devices : https://www.gov.uk/government/news/review-launched-into-the-health-impact-of-potential-bias-in-medical-devices
- WORLD
- USA: Final rule for Medical Device De Novo Classification Process
- Podcast episode 43 – How to register a Medical Device with FDA? (510k, PMA, DeNovo) How to register a Medical Device with FDA? (510k, PMA, de Novo…)
- USA: Draft Guidance 510K Device Software function SaMD
- Webinar Dec 16th, 2021 – Draft Guidance: Content of Premarket Submission for Device Software functions: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-draft-guidance-content-premarket-submissions-device-software-functions-12162021-12162021
- Draft guidance: https://www.fda.gov/media/153781/download
- USA: Voluntary eSTAR Program: https://www.fda.gov/medical-devices/premarket-notification-510k/voluntary-estar-program
- Non-in vitro diagnostic eStar Version 1: https://www.fda.gov/media/154429/download
- In Vitro Diagnostic eStar Version 1: https://www.fda.gov/media/154430/download
- Saudi Arabia: Borderline products https://www.sfda.gov.sa/sites/default/files/2021-11/GuidanceBorderlineProductsClassificationE.pdf
- USA: Final rule for Medical Device De Novo Classification Process
- Notified Body
- SGS Belgium: https://www.sgs.com/en/news/2021/11/sgs-belgium-nv-confirmed-as-a-notified-body-for-the-new-eu-medical-device-regulation-mdr
- MDR 25: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
- IVDR 2017/746 6: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35
- EMD
- Podcast
- Episode 153 – How to improve your QA RA Communication with Lesley Worthington: https://podcast.easymedicaldevice.com/153/
- Episode 154 – Is it possible to Private Label a Medical Device under MDR and IVDR with Erik Vollebregt: https://podcast.easymedicaldevice.com/154/
- Episode 155 – How to approach your Notified Bodies? With Dr Royth von Hahn https://podcast.easymedicaldevice.com/155/
- Episode 156 – Unleashing “MDR Classification surprises with Franck Matzek https://podcast.easymedicaldevice.com/156/
- LinkedIn Live
- Talk Cybersecurity during MDR audit with Stefan Bolleininger: https://www.youtube.com/watch?v=IK0DiXnISKE&t=4s
- IVDR 2017/746 – in-house devices: https://www.youtube.com/watch?v=AbwaA7DpbYI
- Podcast
The post Medical Device News: December 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
289 jaksoa
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