Easy Medical Device Podcast

https://www.youtube.com/embed/8pQBphL1ACQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

We always think that what is most important in QA RA is to know the regulation. NO!.

What is most important is to be able to transmit this knowledge to the other colleagues within your company.

But to do that you need to understand certain parameters and this is what we will discuss today with Lesley Worthington. This podcast will help you improve your communication skill by understanding the situation.

Who is Lesley Worthington?

Lesley is a Toronto-based Communication Skills and Writing Coach for professionals working in medical devices, pharma, and biotechnology.

She combines her passion for empowering others, her passion for words, and her two decades of experience in a Quality Assurance/Regulatory Affairs role to help others become more impactful in their careers.

She works with non-native English speakers looking for guidance and improved confidence in navigating an English-speaking business world. And she works with native and non-native English speakers to adjust their writing for the business world and shows them the power of plain language in connecting with others, reducing mistakes and misunderstandings, saving time, spreading ideas, and getting things done.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing 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…

Links from the Video

• Lesley Worthington Linkedin: https://www.linkedin.com/in/lesleyworthington/
• QA RA Mindset with Michelle Lott: https://podcast.easymedicaldevice.com/114/

The post How to improve your QA RA Communication with Lesley Worthington? 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.

Lesley Worthington is a career coach and will help you understand why improving your communication skills within QA RA can be a booster for you. We will talk about our experience as she also worked in QA RA. So don't miss this episode if you don't understand why your communication activities are not helping you. The post How to improve your QA RA Communication with Lesley Worthington? appeared first on Medical Device made Easy Podcast.

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

In this episode of the Podcast we will review:

• IVDR proposal to delay transition periods
• Cobalt on medical devices as CMR
• Artificial Intelligence
• MDCG guidance
• Notified Body overview

Check links below

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing 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, podcasts, Online courses…

Links

• Implementing Rolling Plan https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_rolling-plan_en.pdf
• IVDR proposal for new transition period: https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5209 https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_5210
  • PDF Q&A: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_21_5210/QANDA_21_5210_EN.pdf
  • Draft Regulation: https://ec.europa.eu/health/sites/default/files/md_newregulations/docs/md_2017-746-regulation_2021-amendment_en.pdf
• ANSM: From October 1st 2021 Cobalt as CMR following 2020/2017: https://ansm.sante.fr/actualites/evolution-reglementaire-impactant-les-dispositifs-medicaux-qui-contiennent-du-cobalt
• Listed on CLP 1272/2008 Annex VI: https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=celex%3A32008R1272
• Guideline to justify CMR is called SCHEER which provides elements to justify with benefit/risk analysis. https://ec.europa.eu/health/sites/default/files/scientific_committees/scheer/docs/scheer_o_015.pdf
• TEAM NB – Proposal for Notified Body Opinion Template for Article 117: https://www.team-nb.org/wp-content/uploads/2021/10/Team-NB-PositionPaper-Article117-NB-Opinion-Template-V1.pdf
• TEAM NB – European Artificial Intelligence: https://www.team-nb.org/wp-content/uploads/2021/10/Team-NB-PositionPaper-Artificial-Intelligence.pdf
• UK MHRA – US, Canada and UK identified 10 guiding principles for AI softwares https://www.gov.uk/government/publications/good-machine-learning-practice-for-medical-device-development-guiding-principles
• UK MHRA – Consultation on Futur Regulation https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom
• UK MHRA – Infusion Pump T34 from BD https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1026856/T34_syringe_pump_guidance_for_gov-uk.pdf
• MHRA Board meeting held in public – eventbrite: https://www.eventbrite.co.uk/e/mhra-board-meeting-held-in-public-tickets-195778337277
• Turkey
  • EU MDR 2017/745 – May 2021 https://titck.gov.tr/storage/Archive/2021/announcement/Ek1TbbicihazGBOKbeyanmetni_83778294-b01e-47a2-b868-e33c1dd02bc3.pdf
  • EU IVDR 2017/746 – Sept 2021 https://titck.gov.tr/storage/Archive/2021/announcement/Ek2InvitroGBOKbeyanmetni_1d33cd35-632a-4abb-87ea-803ef67f4977.pdf
• Philippine – FDA Circular for retailers of Medical Devices – License to sell medical devices is needed https://www.fda.gov.ph/wp-content/uploads/2021/10/FDA-Circular-No.2021-021.pdf • Thailand FDA – HAS Singapore – Regulatory reliance program: https://bit.ly/3nN1PBo
• Japan – PMDA update https://www.pmda.go.jp/files/000243366.pdf
  • Online platform to learn the regulation in Japan: https://www.pmda.go.jp/english/int-activities/training-center/0005.html
  • Other course: https://www.pmda.go.jp/english/int-activities/training-center/0006.html
• EVENTS
  • ACRAS – Nov 24th and 25th https://acras.me/
• NOTIFIED BODIES
  • Overview of Notified Body Situation https://ec.europa.eu/health/sites/default/files/md_newregulations/docs/notifiedbodies_overview_en.pdf
• GUIDANCE
  • MDCG 2021-24 – Classification https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf
  • MDCG 2021-25 Legacy devices https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_25_en.pdf
  • MDCG 2021-26 Article 16 Importer Distr Q&A https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_26_en.pdf
• PODCAST
  • Episode 149 – EUDAMED Update with Richard Houlihan https://podcast.easymedicaldevice.com/149/
  • Episode 150 – CMR substances with Ana Luiza Cassin Duz https://podcast.easymedicaldevice.com/150/
  • Episode 151 – IVDR is not postponed with Erik Vollebregt https://podcast.easymedicaldevice.com/151/

The post Medical Device News – November 2021 latest update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Latest update will focus on IVDR proposal, Artificial intelligence, Notified Bodies situation and MDCG guidances. Other elements will also be discussed. I hope you'll enjoy! The post Medical Device News – November 2021 latest update appeared first on Medical Device made Easy Podcast.

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

A few weeks ago, we were surprised to hear that the EU Commission issued a proposal to delay some products from applying IVDR 2017/746 by my 26th, 2022.

So we decided to discuss this proposal with Erik Vollebregt and see how this should be interpreted as this is not a postponement that is proposed but more some phase application per product class.

Erik presented also during this session a diagram that he has made. I asked him to be able to provide that to you so check in the links below to find it.

You can also read more of this proposal on Erik’s blog. The link is also below.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A.

Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing 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, podcasts, Online courses…

Links

• Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyers: https://www.axonlawyers.com/
• Erik’s blog: https://medicaldevicelegals.com
• PDF – IVDR 2017/746 transition Erik Vollebregt: https://podcast.easymedicaldevice.com/wp-content/uploads/2021/10/Podcast-151-IVDR-grace-periods-Erik-Vollebregt.pdf
• IVDR 2017/746 EU Proposal: https://ec.europa.eu/health/sites/default/files/md_newregulations/docs/md_2017-746-regulation_2021-amendment_en.pdf

The post How does the EU Commission plan to save IVDR 2017/746? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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BREAKING NEWS: The EU Commission issued a proposal to delay some IVDR date of application but it is not a complete postponment so don't use this word. Listen the interpretation of Erik Vollebregt on that. The post How does the EU Commission plan to save IVDR 2017/746? appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/a8_1vaWODe8?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this episode, we will discuss CMR which are some substances that can be dangerous for your health. They are classified by legislation and we will explain to you what you should do.

Ana Luiza Cassin Duz, Clinical Specialist will help us to define what are the MDR requirements and how you can follow the rules and be compliant. In a previous episode, Martin Witte from TÜV SÜD explained that one of the common issues discovered during an MDR audit is the fact that manufacturers were not looking at CMR substances on their products.

So I hope this episode will provide you with all the methods you have to follow to be EU MDR 2017/745 compliant.

Who is Ana Luiza Cassin Duz?

She holds a Bachelor’s Degree in Biological Sciences, a Master’s Degree in Cellular Biology, a Ph.D. in Biological Sciences, and an MBA in Quality Management.

She has worked for the past 10 years in the quality, regulatory and clinical evaluation of various types of medical devices, such as Biological Heart Valve, Endoprosthesis, Inorganic valved conduit, Annular Rings; as well as, Extracorporeal circulation machine, Defibrillator, Cardioverter, and Patient monitors; in addition to Intrastromal corneal ring, Intraocular lens, and Contact lenses.

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 a 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, podcasts, online courses…

Links

• Ana Luiza Cassin Duz Linkedin Profile: https://www.linkedin.com/in/ana-luiza-cassin-duz-clinical/
• ISO 10993-1 standard: https://www.evs.ee/en/evs-en-iso-10993-1-2020
• TUV SUD Biological Evaluation: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/iso-10993-biological-evaluation-of-medical-devices
• Guideline on Phtalate in Medical Devices: https://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scheer_consultation_08_en
• Scheer: https://titck.gov.tr/storage/Archive/2019/contentFile/EK-22-SCHEER%20Guideline%20on%20the%20benefit-risk%20assessment%20of%20the%20presence%20of%20phthalates%20in%20certain%20medical%20devices_3f032f9a-2bba-4e6b-91ac-f4ab0353d367.pdf
• Blood Transfusion association: https://www.edqm.eu/sites/default/files/medias/fichiers/Transfusion/Events/impact_of_mdr_on_the_suppliers_and_their_relations_with_blood_establishments_by_pascale_van_hoydonck.pdf

The post How to comply with MDR when products contain CMR Substances? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Ana Luiza is my guest and we will explain to you how to be sure that your are compliant with CMR substances on your product. CMR will be reviewed during an audit and apparently there were a lot of mistakes. So let's help you to avoid that. The post How to comply with MDR when products contain CMR Substances? appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/B4AbITzsGqI?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Recently EUDAMED made a major Update which was the release of the Device registration module. This is something that all Medical Device manufacturers need to listen to as this may impact their workload.

Richard Houlihan from Eudamed.com accepted to come and tell us more about this update and provide you also with some advice on how to manage it.

So we will talk:

• EUDAMED progress
• EUDAMED Device registration module
• Should you register now or later
• Should you do it manually or use a service provider

Richard Houlihan is also providing training to your team on how to implement EUDAMED so don’t miss it. The links are below.

Who is Richard Houlihan?

Richard Houlihan has been in IT-related businesses for 25+ years. He holds a BSc in Computing and an MBA in Information management. The varying IT roles have led to him living in several countries, working across 6 blue chips, 3 start-ups, and 3 different directorates within the European Commission.

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, podcasts, Online courses…

Links

• Richard Houlihan Linkedin Profile: https://www.linkedin.com/in/richard-houlihan/
• Eudamed.com website: https://eudamed.com/

Training sessions

• Training: 26th & 27th October https://eudamed.com/index.php/product/live-online-eudamed-training-26th-27th-october-2021/
• Training: 23rd & 24th November https://eudamed.com/index.php/product/live-online-eudamed-training-23rd-24th-november-2021/

For the manufacturers, without too many UDI DI’s an offer that includes our templates.

• Up to 100 UDI DI’s https://eudamed.com/index.php/product/eudamed-saas-100/
• Up to 300 UDI DI’s https://eudamed.com/index.php/product/eudamed-saas-300-udidi/

The post EUDAMED Update: Should you register your medical devices now? 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.

EUDAMED is the database that will provide all the information about your company and your devices. After the release of the Economic Operator module, now there is the release of the Device Registration and Certificate Module. So let's talk about that with Richard Houlihan from Eudamed.com The post EUDAMED Update: Should you register your medical devices now? appeared first on Medical Device made Easy Podcast.