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Home > Medical Device made Easy Podcast > Medical Device News – January 2021 Update (Monir El Azzouzi)


	Podcast:		Medical Device made Easy Podcast
	Episode:		Medical Device News – January 2021 Update (Monir El Azzouzi)
	Category:		Business
	Duration:		00:00:00
	Publish Date:		2021-01-05 09:00:00
	Description:		Subscribe HAPPY NEW YEAR 2021 and all my best wishes to you and your family. Within this Medical Device News monthly episode of the podcast, we are reviewing the situation on: Brexit and the need for UK Responsible person Swixit and Turkxit EUDAMED and PRRC information made public Team NB position papers Training – Notified Body situation UK Approved Body situation MDCG guidance Podcast review Don’t forget that Easy Medical Device can be your UK Responsible Person or also your EU REP contact us at UKREP@easymedicaldevice.com 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 HOT TOPICS. UK Rep from Jan 1st, 2021: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market-from-1-january-2021 Easy Medical Device UK Rep: https://easymedicaldevice.com/uk-responsible-person/ Erik Vollebregt Brexit post: https://medicaldeviceslegal.com/2020/12/28/the-brexit-deal-whats-not-in-it-for-the-medical-devices-industry/ Survey Swixit Turkxit: https://www.linkedin.com/posts/melazzouzi_medicaldevices-easymedicaldevice-regulatoryaffairs-activity-6751203793725116416-lPjR Rolling Plan: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_rolling-plan_en.pdf EUDAMED PRRC question: https://www.linkedin.com/posts/ronald-boumans-34790055_eudamed-prrc-gdpr-activity-6745368549667155969-RzNv TEAM-NB Drug-Device Position Paper: https://www.team-nb.org/wp-content/uploads/2020/12/Team-NBPosition-Paper-Art117SubChangeLifeCycleMngt-202012.pdf MDCG 2020-3 on Significant changes: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_guidance_significant_changes_annexes_en.pdf TRAINING: Green Belt Certificate: https://school.easymedicaldevice.com/gb/ NOTIFIED BODIES: NANDO EU MDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 TEAM NB Expiring certificates: https://www.team-nb.org/wp-content/uploads/2020/12/Team-NB-PositionPaper-ExpiringCertificates-20201215.pdf Survey: EU MDR & IVDR postponement: https://www.linkedin.com/posts/melazzouzi_there-were-a-lot-of-requests-related-to-the-activity-6751181775264890880-FWOK The UK approved bodies: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies GUIDANCES: MDCG guidance Lenses 2020-18: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_18_en.pdf Ongoing guidance: https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_ongoing_guidancedocs_en.pdf PODCAST: How to register a Medical Device in Mexico https://podcast.easymedicaldevice.com/106/ How to deal with Significant Changes with Martin Witte https://podcast.easymedicaldevice.com/107/ How Easy Medical Device can help you? https://podcast.easymedicaldevice.com/108/ The post Medical Device News – January 2021 Update (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast.
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