Medical Device News: What happened in November 2020?
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/
The post Medical Device News: What happened in November 2020? appeared first on Medical Device made Easy Podcast.
