Easy Medical Device Podcast

https://www.youtube.com/embed/PSk7JtreZvg?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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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. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

In this monthly episode we will review what happened within the Medical Device industry. EUDAMED, Covid19, Notified Bodies... The post What is the Medical Device News? [March 2021 update] appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/-WqOtzkiM5E?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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I am really honored to have within this episode of the Podcast Jon Speer. I was already following him before I started Easy Medical Device and now I had the opportunity to interview him.

We discussed Medical Device Design, and I wanted his opinion on the best design methodology to use and which trap to not fall in.

We discussed particularly the famous FDA waterfall diagram and the Agile methodology.

So if you are a company developing Medical Devices, this is an episode that you should not miss.

Who is Jon Speer?

Jon Speer is the founder of Greenlight Guru, a medical device quality management software solution.

Jon is a medical device guru with over 22 years of industry experience who knows the best medical device companies in the world use quality as an accelerator.

That’s why he created Greenlight Guru to help companies move beyond compliance to achieve True Quality.

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

Lately, Monir created the Easy Medical Expert platform where you can submit some missions, and experts in the Medical Device field will be able to answer and help you.

Links

• Jon Speer LinkedIn profile: https://www.linkedin.com/in/jondspeer/
• Greenlight Guru: https://www.greenlight.guru
• FDA Guidance – Design control: https://www.fda.gov/media/116573/download
• Jon speer email: [email protected]
• Easy Medical Expert: http://easymedicalexpert.com

The post The best design methods for successful development? [Jon Speer] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Waterfall or Agile? Jon Speer from Greenlight Guru will help to understand what is the best methodology that can be used to develop your medicaldevices. The post The best design methods for successful development? [Jon Speer] appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/RV95nolA410?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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If you find it difficult to get a job in QA RA for Medical Devices, then listen to this episode where Monir El Azzouzi and Karandeep Badwal are giving you some tips on how to integrate this world.

They will provide you some tools to use, some podcasts to listen to, some groups to follow. And for sure this will move you few steps forward. If you have any questions, don’t hesitate to ask in the comments.

Who is Karandeep Badwal?

Mr. Karandeep Singh Badwal is a Regulatory and Quality Contractor specializing in medical devices.

His educational background is an MSc Pharmaceutical Quality by Design, however, has worked almost exclusively within the medical devices industry from multinational companies to startups since his graduation.

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

Links

• QRA Medical Youtube channel: https://www.youtube.com/c/qramedical
• Karandeep Linkedin: https://www.linkedin.com/in/karandeepbadwal/
• Easy Medical Device Linkedin: https://www.linkedin.com/company/easymedicaldevice
• Kolabtree: https://www.kolabtree.com/
• Quality Engine: https://quality-engine.com/
• Telegram EasyMedicalDevice: https://t.me/easymedicaldevice
• MDG premium: https://www.medicaldevicesgroup.net/premium/
• Lean RAQA Today: https://soundcloud.com/raqatoday
• Greenlight Guru Podcast: https://www.greenlight.guru/podcasts
• Qmed Podcast: https://www.qmed-consulting.com/podcasts.html
• Medtech Future: https://anchor.fm/medtechfutures
• Medical Device made Easy Podcast: https://podcast.easymedicaldevice.com

The post How to find a QA RA job for Medical Devices? [Karandeep Badwal] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

How to find a job in the QA RA world for Medical Devices? This is what we will discuss with Karandeep Badwal. We will provide our tips and also the platforms to visit. The post How to find a QA RA job for Medical Devices? [Karandeep Badwal] appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/BSsHCkwpt58?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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Michelle Lott and I are discussing our Experience in the Quality and Regulatory affairs area. We will help you define what is compliance and how we think it should be applied. Michelle had also some good and bad experiences that she is sharing with us.

Who is Michelle Lott?

Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries. She has a weakness for tequila and anything barbecued.

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 from the Video

• Linkedin Michelle Lott: https://www.linkedin.com/in/michellelottraqa/
• Lean RAQA Website: https://leanraqa.com/
• Lean RAQA Today Podcast: https://soundcloud.com/raqatoday
• Blog Post “What is Quality?”: https://easymedicaldevice.com/what-is-quality/

The post What is the QA RA Mindset with Michelle Lott appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

If you are thinking that you are the only one that has issues as QA RA, then listen to this episode. I hope this will help you to understand that there is a certain mindset to have when you do this type of job. The post What is the QA RA Mindset with Michelle Lott appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/RXLmLbq9mpA?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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In this monthly episode of the podcast, we do a regulatory intelligence review of what happened monthly.

The agenda for this month is:

• Countdown until EU MDR by Michelle Lott (LeanRAQA)
• Remote Audit authorized for EU MDR
• SURVEY Result
• US update on Recognised Consensus Standards
• Canada guidance on Vigilance Reporting
• Training available
• Notified Body Situation
• UK Approved Body
• Guidance and Standards
• PODCAST and LIVE episodes

Look at all the links below.

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

LinksHOT TOPICS

• Remote audit Commission Notice 2021/C 8/01 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.C_.2021.008.01.0001.01.ENG&toc=OJ%3AC%3A2021%3A008%3ATOC
• Erik Vollebregt Blog https://medicaldeviceslegal.com/2021/01/24/finally-remote-initial-audits-or-not/
• TEAM NB is working on a harmonized view regarding the commission notice published https://www.team-nb.org/team-nb-task-force-is-working-on-harmonised-views-on-harmonised-risk-based-approach-regarding-commission-notice-published-today-2/
• Podcast episode 33 – https://podcast.easymedicaldevice.com/33/
• NEW SURVEY: Under all those circumstances do you think the EU COMMISSION took the right decision. https://www.linkedin.com/posts/melazzouzi_medicaldevices-easymedicaldevice-regulatoryaffairs-activity-6761649059909419009-h5u2
• SURVEY result: MDR IVDR postponement: https://www.linkedin.com/posts/melazzouzi_there-were-a-lot-of-requests-related-to-the-activity-6751181775264890880-FWOK/
• SURVEY: Swiss/Turkey Certificates: https://www.linkedin.com/posts/melazzouzi_medicaldevices-easymedicaldevice-regulatoryaffairs-activity-6751203793725116416-lPjR/

TRAINING

• Qmed Academy: https://qmed-academy.teachable.com/
• EUDAMED (Eudamed.eu). https://eudamed.eu/index.php/mdr-eudamed-training-schedule/
• QUINIQUE: https://quniquegroup.com/trainings/
• Easy Medical Device: https://school.easymedicaldevice.com/course/gb9

NOTIFIED BODY

• SGS FIMKO OY (Finland) https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=310591&version_no=17
• NANDO MDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
• NANDO IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35
• UK approved body: ttps://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices

PODCAST & LIVE

• How to register a Medical Device in Israel with Liat Nadel https://podcast.easymedicaldevice.com/110/
• Hot to get the MDR certification for Artificial Intelligence Software’s with Leon Doorn https://podcast.easymedicaldevice.com/111/
• How to perform your PMS more easily with Ivan Perez Chamorro https://podcast.easymedicaldevice.com/112/
• LINKEDIN LIVE: What is the EU MDR timeline? https://www.youtube.com/watch?v=UB6Ze7pebLY

The post February 2021 Update – Medical Devices Remote Audit by the EU appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

On this podcast episode, we'll perform the February 2021 update. What happened in the Medical Device World. One of the HOT TOPICS is the Remote audit authorization by the EU Commission but we'll see this is not so easy. The post February 2021 Update – Medical Devices Remote Audit by the EU appeared first on Medical Device made Easy Podcast.