December 07, 2020

Medical Device News: What happened in November 2020?

32 minutes

https://www.youtube.com/embed/nB8PMi3LXNE?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this monthly review of Medical Device News, we will see what happened this November 2020 for the Medical Device Industry.

During this review, we will check some topics like:

Eudamed

Quality engine

Brexit and UK responsible Person

TEAM NB Position paper with some proposals

Job Opportunities in EU and the US

Greenlight Guru event

TOPRA Award: Who is the winner

Notified Body situation

Guidance

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 company 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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

HOT TOPICS

EUDAMED Actor module FAQ: https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/md_actor_module_q-a_en.pdf

Link EUDAMED Registration: https://webgate.ec.europa.eu/eudamed

Quality Engine: https://quality-engine.com/

Easy Medical Device UK Responsible Person: https://easymedicaldevice.com/uk-responsible-person/

Brexit communication: https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021

TEAM-NB Position paper: https://www.team-nb.org/wp-content/uploads/2020/11/Team-NB-PositionPaper-Team-NB-consideration-paper-on-IVDR-Date-of-Application.pdf

Job ELEMED: https://www.elemed.eu/vacancies/

Job Life Science People: https://www.lifesciencepeople.co.uk/jobs

Job The Anthony Michael Group: https://www.theanthonymichaelgroup.com/opportunities/

TOPRA Award Ceremony: https://www.youtube.com/watch?v=vKJFEFCrrEg

Greenlight Guru Virtual Event: https://2021md.greenlight.guru/?sc=XX1H2oPX&ac=gJxS6x7K

Green Belt Certificate: https://school.easymedicaldevice.com/gb

NOTIFIED BODIES

UDEM Adriatic: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=NANDO_INPUT_232844

GUIDANCES

Agenda for MDCG meeting: https://ec.europa.eu/health/sites/health/files/md_dialogue/docs/md_events_2021_en.pdf

MDCG 2020-16 Classification rules for IVDR: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_guidance_classification_ivd-md_en.pdf

PODCAST EPISODES

Episode 100 – Last 2 years story: https://podcast.easymedicaldevice.com/100/

Episode 101: Common Specifications with Stefan Bolleininger: https://podcast.easymedicaldevice.com/101/

Episode 102: Expert Panels with Bassil Akra: https://podcast.easymedicaldevice.com/102/

Episode 103: Training benefits with SOFMEDICA Team: https://podcast.easymedicaldevice.com/103/

Episode 104: Notified Body accreditation with Caroline Dore Geraghty: https://podcast.easymedicaldevice.com/104/

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