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Medical Device News: September 2022 Regulatory Update
Manage episode 340276649 series 2591977
コンテンツは Monir El Azzouzi によって提供されます。エピソード、グラフィック、ポッドキャストの説明を含むすべてのポッドキャスト コンテンツは、Monir El Azzouzi またはそのポッドキャスト プラットフォーム パートナーによって直接アップロードされ、提供されます。誰かがあなたの著作権で保護された作品をあなたの許可なく使用していると思われる場合は、ここで概説されているプロセスに従うことができますhttps://ja.player.fm/legal。
Here are the links to the Regulatory Updates
HOT TOPIC
- EUDAMED Timeline https://health.ec.europa.eu/system/files/2022-07/md_eudamed_timeline_en.pdf
- EU Call for application submission of EU Reference laboratories. https://health.ec.europa.eu/latest-updates/call-eu-reference-laboratories-sent-member-states-2022-08-05_en
- HPRA & Spain – EU Commission call for Member states application of EU Reference labs for IVDs (EURLs) – http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/european-commission-publishes-call-for-european-union-reference-laboratories-for-ivds-designation&id=619f1226-9782-6eee-9b55-ff00008c97d0
- https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/instrucciones-para-la-presentacion-de-solicitudes-de-designacion-de-laboratorios-de-referencia-de-la-ue-para-productos-sanitarios-de-diagnostico-in-vitro/
- Clinical Evaluation Consultation Procedure
- CECP Class III implantable tricuspide valve procedure https://health.ec.europa.eu/latest-updates/expert-decision-and-opinion-context-clinical-evaluation-consultation-procedure-cecp-2022-08-24_en
- CECP 2022-000213 Transcatheter heath valve https://health.ec.europa.eu/document/download/3ed8dacb-2b9d-4096-bc84-0b408f8492c4_en?filename=cecp-2022-000213_opinion_en.pdf
- Draft Reclassification of Annex XVI products https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en
- ROW
- SFDA introduction to regulation Workshop – REMOTELY: https://www.sfda.gov.sa/en/workshop/87146
- SAHPRA Guidances on clinical trial
- https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-07_v4-Guideline-for-Post-Clinical-Trial-Access.pdf
- https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-06_v2-Guideline-for-The-Procedure-of-Consultation-Meetings-with-Clinical-Trial-Applicants.pdf
- https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-04-Oversight-and-Monitoring-in-Clinical-Trials_August-2022_V4.pdf
- https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-03-Emergency_Procedures_Clinical_Trial_Sites_August-2022_v3.pdf
- China – Guidance for registration of percutaneous Enteral Nutrition Catheter and Disposable Human Arterial Blood Samplers https://www.cmde.org.cn/flfg/zdyz/zqyjg/zqyjgwy/20220826111515137.html
- India: List of certified Medical Device Testing Laboratories under MDR 2017 https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODg4Mg==
- Australia TGA – Regulatory Guidelines for Medical Devices https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd
TRAINING
- Green Belt Session 20: https://school.easymedicaldevice.com/product/gb/
- Scube Technologies: https://scube-technologies.com/
NOTIFIED BODIES
- 32nd NB MDR – Bureau Veritas Italia https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=318721&version_no=15
GUIDANCES
- MDCG 2022-13 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf
- MDCG 2022-14 Transition to the MDR and IVDR: https://health.ec.europa.eu/system/files/2022-08/mdcg_2022-14_en.pdf
EASY MEDICAL DEVICE PODCAST
- Medtech Europe Forum Interview https://podcast.easymedicaldevice.com/188/
- AI Act Erik Vollebregt https://podcast.easymedicaldevice.com/189/
- Cleanroom Philippe Bourbon Icare https://podcast.easymedicaldevice.com/190/
- How to create a Technical File https://podcast.easymedicaldevice.com/191/
- When you think 510k but FDA says DeNovo with Spencer Jones Lineus Medical https://podcast.easymedicaldevice.com/192/
- Discontinuation process with Alexandros Savvidis https://podcast.easymedicaldevice.com/193/
- New Blue Guide Erik Vollebregt https://podcast.easymedicaldevice.com/194/
- SaMD and SiMD Design Dossier Anindya Mookerjea https://podcast.easymedicaldevice.com/195/
The post Medical Device News: September 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
290 つのエピソード
Manage episode 340276649 series 2591977
コンテンツは Monir El Azzouzi によって提供されます。エピソード、グラフィック、ポッドキャストの説明を含むすべてのポッドキャスト コンテンツは、Monir El Azzouzi またはそのポッドキャスト プラットフォーム パートナーによって直接アップロードされ、提供されます。誰かがあなたの著作権で保護された作品をあなたの許可なく使用していると思われる場合は、ここで概説されているプロセスに従うことができますhttps://ja.player.fm/legal。
Here are the links to the Regulatory Updates
HOT TOPIC
- EUDAMED Timeline https://health.ec.europa.eu/system/files/2022-07/md_eudamed_timeline_en.pdf
- EU Call for application submission of EU Reference laboratories. https://health.ec.europa.eu/latest-updates/call-eu-reference-laboratories-sent-member-states-2022-08-05_en
- HPRA & Spain – EU Commission call for Member states application of EU Reference labs for IVDs (EURLs) – http://www.hpra.ie/homepage/medical-devices/news-events/item?t=/european-commission-publishes-call-for-european-union-reference-laboratories-for-ivds-designation&id=619f1226-9782-6eee-9b55-ff00008c97d0
- https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/instrucciones-para-la-presentacion-de-solicitudes-de-designacion-de-laboratorios-de-referencia-de-la-ue-para-productos-sanitarios-de-diagnostico-in-vitro/
- Clinical Evaluation Consultation Procedure
- CECP Class III implantable tricuspide valve procedure https://health.ec.europa.eu/latest-updates/expert-decision-and-opinion-context-clinical-evaluation-consultation-procedure-cecp-2022-08-24_en
- CECP 2022-000213 Transcatheter heath valve https://health.ec.europa.eu/document/download/3ed8dacb-2b9d-4096-bc84-0b408f8492c4_en?filename=cecp-2022-000213_opinion_en.pdf
- Draft Reclassification of Annex XVI products https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en
- ROW
- SFDA introduction to regulation Workshop – REMOTELY: https://www.sfda.gov.sa/en/workshop/87146
- SAHPRA Guidances on clinical trial
- https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-07_v4-Guideline-for-Post-Clinical-Trial-Access.pdf
- https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-06_v2-Guideline-for-The-Procedure-of-Consultation-Meetings-with-Clinical-Trial-Applicants.pdf
- https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-04-Oversight-and-Monitoring-in-Clinical-Trials_August-2022_V4.pdf
- https://www.sahpra.org.za/wp-content/uploads/2022/08/SAHPGL-CEM-CT-03-Emergency_Procedures_Clinical_Trial_Sites_August-2022_v3.pdf
- China – Guidance for registration of percutaneous Enteral Nutrition Catheter and Disposable Human Arterial Blood Samplers https://www.cmde.org.cn/flfg/zdyz/zqyjg/zqyjgwy/20220826111515137.html
- India: List of certified Medical Device Testing Laboratories under MDR 2017 https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODg4Mg==
- Australia TGA – Regulatory Guidelines for Medical Devices https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd
TRAINING
- Green Belt Session 20: https://school.easymedicaldevice.com/product/gb/
- Scube Technologies: https://scube-technologies.com/
NOTIFIED BODIES
- 32nd NB MDR – Bureau Veritas Italia https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=318721&version_no=15
GUIDANCES
- MDCG 2022-13 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies https://health.ec.europa.eu/document/download/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf
- MDCG 2022-14 Transition to the MDR and IVDR: https://health.ec.europa.eu/system/files/2022-08/mdcg_2022-14_en.pdf
EASY MEDICAL DEVICE PODCAST
- Medtech Europe Forum Interview https://podcast.easymedicaldevice.com/188/
- AI Act Erik Vollebregt https://podcast.easymedicaldevice.com/189/
- Cleanroom Philippe Bourbon Icare https://podcast.easymedicaldevice.com/190/
- How to create a Technical File https://podcast.easymedicaldevice.com/191/
- When you think 510k but FDA says DeNovo with Spencer Jones Lineus Medical https://podcast.easymedicaldevice.com/192/
- Discontinuation process with Alexandros Savvidis https://podcast.easymedicaldevice.com/193/
- New Blue Guide Erik Vollebregt https://podcast.easymedicaldevice.com/194/
- SaMD and SiMD Design Dossier Anindya Mookerjea https://podcast.easymedicaldevice.com/195/
The post Medical Device News: September 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
290 つのエピソード
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