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Home > Medical Device made Easy Podcast > What is the Medical Device News? [March 2021 update]


	Podcast:		Medical Device made Easy Podcast
	Episode:		What is the Medical Device News? [March 2021 update]
	Category:		Business
	Duration:		00:00:00
	Publish Date:		2021-03-02 00:00:00
	Description:		Subscribe This month we will review what happened within the Medical Device Industry and there was some updates. Here is the agenda: EUDAMED Covid19 Language for EU MDR 2017/745 MHRA virtual manufacturer update Australia Nanoparticle consultation Singapore Medical device grouping tool Saudi Arabia covid 19 update Easy Medical Expert Green Belt Training Notified Bodies Approved Bodies Events Podcast episodes Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses… Links EUDAMED EU Commission EUDAMED Legacy devices: https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/legacy_dvc_management_en.pdf EUDAMED-DI Free Generator Template: https://eudamed.eu/index.php/eudamed-legacy-device-di-generator/ MDCG 2019-15 Legacy device https://ec.europa.eu/docsroom/documents/34922/attachments/1/translations/en/renditions/native MDCG 2021-1 EUDAMED Harmonized practices: https://ec.europa.eu/health/sites/health/files/md_sector/docs/2021-1_guidance-administrative-practices_en.pdf COVID 19 Section TEAM-NB position paper – Commission Notice 2021/C 8/01: https://www.team-nb.org/it-appears-that-there-are-differences-in-the-approach-between-member-states-and-national-competent-authorities-concerning-the-implementation-the-commission-notice-2021-c-8-01-on-remote-audits-under-th/ Survey result: https://www.linkedin.com/posts/melazzouzi_medicaldevices-easymedicaldevice-regulatoryaffairs-activity-6761649059909419009-h5u2/ COVID-19 tests: https://ec.europa.eu/health/sites/health/files/md_sector/docs/covid-19_ivd-qa_en.pdf Clinical Trials during Covid-19: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf OTHER Norwegian: https://legemiddelverket.no/Documents/Medisinsk%20utstyr/Spr%C3%A5kkrav/Language%20requirement.pdf MHRA Virtual manufacturer Version 3 including elements about Brexit rules: https://www.gov.uk/government/publications/medical-devices-virtual-manufacturing-replaces-own-brand-labelling/virtual-manufacturing-of-medical-devices WORLD Australia: Consultation on Nanoparticles: https://consultations.health.gov.au/tga/medical-devices-nanomaterials/ Mask test results b TGA: https://www.tga.gov.au/testing-face-masks-and-respirators Singapore: Introduction of the Medical Device grouping tool: https://consultations.health.gov.au/tga/medical-devices-nanomaterials/ Saudi Arabia: Support of Medical Devices due to the pandemic http://www.ahwp.info/sites/default/files/Kingdom%20of%20Saudi%20Arabia%20updates_0.pdf TOOL Easy Medical Expert http://easymedicalexpert.com Green Belt Certificate 10th Edition: https://school.easymedicaldevice.com/course/gb10 Notified Body Instituto Superior di Sanita. https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=311094&version_no=3 NANDO EU MDR Notified Bodies: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 NANDO EU IVDR Notified Bodies: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35 UK Approved body: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices Events Virtual Summit Greenlight Guru: March 17th – How to create labels per EU MDR? https://www.linkedin.com/events/eumdr-ivdrtruequalitysummitseri6766032051045986304/ Podcast episodes Podcast Episode 114 – What is the QA RA Mindset with Michelle Lott from Lean RAQA https://podcast.easymedicaldevice.com/114/ Podcast Episode 115 – How to find a QA RA Job with Karandeep Badwal https://podcast.easymedicaldevice.com/115/ Podcast Episode 116 – Medical Device Design methods (Waterfall or Agile) Jon speer from Greenlight Guru https://podcast.easymedicaldevice.com/116/ Telegram group: https://t.me/easymedicaldevice The post What is the Medical Device News? [March 2021 update] appeared first on Medical Device made Easy Podcast.
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