Easy Medical Device Podcast

https://www.youtube.com/embed/4bboTY74eAI?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Within this Masterclass, I will explain to you how to implement a vigilance reporting system with all the links for all the documents we talk about.

Vigilance reporting is a system that you need to have in place for your Quality Management System even if you are still MDD compliant.

If you get a serious incident or a Field Safety Corrective Action (FSCA) then below are the steps to follow.

In this episode of the podcast, we will talk about

• What to do when there is an incident?
• When to report?
• Who to report to?
• How to report?
• Investigation
• Field Safety Notice
• Significant Changes

Below you will have all the links.

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…

Links from the Video

• Q&A MIR form https://ec.europa.eu/docsroom/documents/41322/attachments/1/translations/en/renditions/native
• MIR Form: https://ec.europa.eu/docsroom/documents/41681/attachments/1/translations/en/renditions/native
• FSN Form: https://ec.europa.eu/docsroom/documents/32521/attachments/1/translations/en/renditions/native
• FSN – Customer reply: https://ec.europa.eu/docsroom/documents/32516/attachments/1/translations/en/renditions/native
• FSN Distributor/Importer reply: https://ec.europa.eu/docsroom/documents/32517/attachments/1/translations/en/renditions/native
• FSN Q&A: https://ec.europa.eu/docsroom/documents/31933/attachments/1/translations/en/renditions/native
• IMDRF terminologies for categorized Adverse Event Reporting (AER): http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-200318-ae-terminologies-n43.pdf
• IMDRF annexes: http://www.imdrf.org/documents/documents.asp
• Periodic Summary Report (PSR) form: https://ec.europa.eu/docsroom/documents/32305/attachments/7/translations/en/renditions/pdf
• IMDRF Trend Reporting Guideline: http://www.imdrf.org/docs/ghtf/final/sg2/technical-docs/ghtf-sg2-n36r7-2003-manufacturer-trend-reporting-adverse-event-030101.pdf
• MDCG 2020-3 Significant changes: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_guidance_significant_changes_annexes_en.pdf
• Medtech Europe revised Incident Reporting form: https://www.medtecheurope.org/news-and-events/news/revised-manufacturer-incident-reporting-form-and-new-vigilance-related-guidance-documents-published/
• Cardiac implantable Electronic Devices (CIED) – Guidance on the vigilance system: https://ec.europa.eu/docsroom/documents/37283?locale=en
• Breast Implants – Guidance on the vigilance system: https://ec.europa.eu/docsroom/documents/37283?locale=en

The post How to implement Vigilance Reporting for MDR and IVDR? 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.

Vigilance Reporting is an important system to have within your quality management system. Even if you are still MDD, you need to comply to the MDR requirements for it. So I will help you for that. The post How to implement Vigilance Reporting for MDR and IVDR? appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/goY0i8fmcNY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this second episode on System and Procedure Pack, we answer more questions about this way to place devices on the market. Erik got some experience with the authorities that he will share with us and I have created some cases that I will propose to Erik and see how he would manage them. Erik will also talk more about IVDR as this is a topic of high importance. Erik will also tell us more about his book. Follow the links for more details.

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 for 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 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 from the Video

• Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyers: https://www.axonlawyers.com/
• Erik’s blog: https://www.axonlawyers.com/author/erikvollebregt/?archive
• Episode 119 System and procedure pack: https://podcast.easymedicaldevice.com/119/
• MDCG EUDAMED Q&A: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2021-13_q-a-actor_registr_eudamed_en.pdf

The post System and Procedure Pack the RETURN with Erik Vollebregt 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.

After receiving a lot of questions on System and Procedure pack we have decided to have a second episode on it with Erik Vollebregt. So let's review some special cases and also some feedback from the authorities. The post System and Procedure Pack the RETURN with Erik Vollebregt appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/1RsFhuir0TY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

We received the First Expert Panel Opinion and by reading it you can say a lot. So to help us have a good interpretation of it, I have asked Bassil Akra to be my guest on this podcast episode.

We will remind you what is the Expert Panel, then we’ll discuss more deeply the Opinion received and finally, we will provide you some advice on how to avoid certain issues when you have to go through this process.

If you want to get this document, you have the link below.

Who is Dr. Bassil Akra?

Dr. Bassil Akra, CEO of Akra Team has a background in research, development, regulatory approval, and quality management of medical devices. Within his role at TÜV SÜD, Dr. Akra was a member of various Medical Device Regulation (MDR) European task forces, to help with the interpretation of the new legislation towards a smooth transition into May of 2020. In addition to his work as a senior field expert for TÜV SÜD, Dr. Akra presents worldwide on the European requirements and was involved in the development of many guidance documents and standards.

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

• Akra team website: https://www.akrateam.com
• Bassil Akra Linkedin Profile: https://www.linkedin.com/in/bassil-akra-2388b84b/
• Episode 102 – What are expert panels with Bassil Akra: https://podcast.easymedicaldevice.com/102/
• First Expert Panel Opinion: https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/2021-000201_nb0483_opinion.pdf
• Clinical Pack: https://school.easymedicaldevice.com/product/clinical_pack/

The post How to interpret the first Expert Panel Opinion? [Bassil Akra] 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.

Bassil Akra will help use interpret this first Expert Panel Opinion. Bassil already helped on a previous episode where we discussed about the creation of this Expert Panel. Let's review this first outcome and see the consequence of it for the industry. The post How to interpret the first Expert Panel Opinion? [Bassil Akra] appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/hpn7PDIYD_s?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 provide an update on the Medical Device industry for the period June July 2021.

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

• Joint implementation and preparedness plan for Regulation MDR 2017/745 on IVDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_joint-impl-plan_en.pdf
• TEAM-NB: CIRCABC Remote Audit Analysis: https://www.team-nb.org/wp-content/uploads/2021/06/CIRCABC-Remote-Audit-Analysis-May-2021.pdf
• Q&A for applicants, MAH of medicinal products with respect to MDR and IVDR: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf
• Drug Device Dossier template: https://school.easymedicaldevice.com/product/drug-device-tech-doc/
• The First opinion of the scientific panels in the fields of medical devices: https://ec.europa.eu/health/sites/default/files/md_expertpanels/docs/2021-000201_nb0483_opinion.pdf
• Webinar: Respirators and other PPE during Covid 19: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-series-respirators-and-other-personal-protective-equipment-ppe-health-care-personnel-use
• Medwatch Adverse experience reporting (AER): https://www.federalregister.gov/documents/2021/06/30/2021-13943/agency-information-collection-activities-proposed-collection-comment-request-medwatch-the-food-and
• Virtual Public Workshop – Spinal Device Clinical Review: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-workshop-spinal-device-clinical-review-09172021-09172021
• Dekra Certification B.V. (NB 0344): https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=313231&version_no=22
• MDCG 2021-12 – FAQ on the European Medical Device Nomenclature EMDN: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_2021-12_en.pdf
• EMDN Q&A: https://ec.europa.eu/health/sites/default/files/md_topics-interest/docs/md_q-a_emdn_en.pdf
• MDCG 2021-10 – The status of Appendix E-1 of IMDRF N48: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_2021-10_en.pdf
• IMDRF udi: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-190321-udi-sag.pdf
• MDCG 2021-11 – Guidance on Implant Card “Device Types”: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_2021-11_en.pdf
• MDCG 2019-8 v2 – Guidance document Implant Card: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2019_8_implant_guidance_card_en.pdf
• MDCG 2021-13 – Q&A on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, EAR, importer: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021-13_q-a-actor_registr_eudamed_en.pdf
• SFDA: MDS-G11 Guidance on approval requirements for medical devices advertising: https://www.sfda.gov.sa/sites/default/files/2021-06/MDS-G11ar_en2.pdf
• Episode 131: How to perform a Biological Evaluation for Medical Devices with Ana Luiza Cassin Duz: https://podcast.easymedicaldevice.com/131/
• Episode 132: How to perform a good Clinical investigation with Helene Quie: https://podcast.easymedicaldevice.com/132/
• Episode 133: How intellectual property is linked to the Medical Device Regulation with Stephen Carter: https://podcast.easymedicaldevice.com/133/
• Episode 134: How to build your State-of-the-art with Hakan Inan: https://podcast.easymedicaldevice.com/134/
• Linkedin Live: How to place your UDI on your Medical Device with Christian Söhner: https://www.youtube.com/watch?v=cddwXCf_8e4
• Linkedin Live: Best practices to develop a Medical Device Software: https://www.youtube.com/watch?v=8CqSO_B6_zk

The post Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA] 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.

We will update you on all what happened within the Medical Device regulation. All new The post Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA] appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/TgSIZJ9OxIE?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

State-of-the Art is an important topic but not well understood. It’s why I have invited Hakan Inan from Requalite to help us get a better understanding of this concept that you should use on your Clinical Evaluation or Performance Evaluation. We will talk not only about MDR but also about IVDR as this concept is required for both. Don’t hesitate to go on the show notes to see the documents that can help you with that.

Who is Hakan Inan?

Hakan Inan is the founder and the managing director of Requalite GmbH, Medical device compliance consulting company, with a special focus on Medical writing activities for Performance and clinical evaluation reports as per MDR and IVDR. Hakan holds a PhD in Nanotechnology and has developed in vitro diagnostic devices for cancer applications at Medicine Faculty-Stanford University. Requalite provides support to Medical device and In vitro diagnostic device companies in their compliance journey by designing and creating Performance and Clinical Evaluation Reports. Requalite has a strong team of experts, all with PhD degrees in the scientific fields including immunology, hematology, oncology, neurology, and cardiovascular diseases, etc.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert Specialised in Quality and Regulatory Affairs. He decided to quit his corporate job to start EASY MEDICAL DEVICE. He is now providing support to the Medical Device industry by educating people with his Blog, Podcast, Youtube channel and also helping them through consulting, coaching, and training. He decided to open an office in the UK to be able to support his customers that would need a UK Responsible Person. Easy Medical Device is becoming the one-stop-shop for Medical Device Industry.

Links

• Requalite Website: www.requalite.com
• Linkedin profile: https://www.linkedin.com/in/hakaninan
• Linkedin page: https://www.linkedin.com/company/requalite-gmbh
• MDCG 2021-5: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_5_en.pdf
• IMDRF guidance: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-181031-grrp-essential-principles-n47.pdf

The post How to build your State-of-the-art for your Medical Devices? 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.

The State-of-the Art is one of the component that can make you win or make you lose. If this research is not done correctly, it can ruin your Clinical Evaluation Report or Performance Evaluation Report. Hakan Inan from Requalite will explain to us why this is important. The post How to build your State-of-the-art for your Medical Devices? appeared first on Medical Device made Easy Podcast.