Easy Medical Device Podcast

https://www.youtube.com/embed/1hHE3I9f-lc?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

This month we will cover a lot of specific rules that are applied in some countries:

• USA
• UK
• France
• Finland
• Switzerland

And then we’ll look at Events planned, Notified Bodies, MDCG guidances released, and the Podcast episodes.

Enjoy!

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…

• FDA Shifts to regulating Contrast agents as Devices: https://www.raps.org/news-and-articles/news-articles/2021/8/after-court-defeat-fda-shifts-to-regulating-some-d?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%209%20August%202021
• UK – Export – FSC https://www.gov.uk/guidance/export-medical-devices-special-rules ○ Bfarm – Real time operating system vulnerabilities: https://www.bfarm.de/SharedDocs/Risikoinformationen/Medizinprodukte/EN/vulnerabilities_realtime_os.html;jsessionid=CBCADA5BC2C5210901042A54A3189117.intranet231?nn=968830
• RAPS article on Bfarm alert: https://www.raps.org/news-and-articles/news-articles/2019/8/operating-system-vulnerabilities-in-many-medical-d
• France: Anticipation potential disruption of products: https://ansm.sante.fr/actualites/indisponibilite-dun-dispositif-medical-lansm-publie-une-procedure-de-gestion-preventive-pour-les-operateurs-du-marche
• Finland: MDR supplementing law: https://www.fimea.fi/web/en/-/laws-supplementing-eu-regulations-on-medical-devices-come-into-force
• Switzerland – Obligation CH-REP importer distributors: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/pflichten-bevollmaechtigte.html
• Easy Medical Device Authorized Representative: https://easymedicaldevice.com

• GCC September 20th – 22nd – https://www.gccmedtech.com/
• IMDS September 28th – 29th morning CET – https://www.imdsgroup.com/
• Rentrée du DM October 6th – 7th – https://www.larentreedudm.com/
• Medtech Virtual Summit October 18 – 22nd – https://informaconnect.com/medtech-summit/

• NB – GMED for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.pdf&dir_id=35&ntf_id=314017

• MDCG 2021-21 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-21_en.pdf
• MDCG 2021-22 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-22_en.pdf
• MDCG 2021-23 https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-23_en.pdf

• Episode 140 – What can we learn from the first MDR audits? [Martin Witte – TÜV SÜD] https://podcast.easymedicaldevice.com/140/
• Episode 141 – Better to be a Consultant of a Full-time employee? [Smahan Toughrai Tech’Firm] https://podcast.easymedicaldevice.com/141/
• Episode 142 – How to certify a Software as a Medical Device? [Dr. Abtin Rad TÜV SÜD] https://podcast.easymedicaldevice.com/142/

The post Medical Device News – September 2021 Latest Updates 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.

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Software as a Medical Device is really a difficult topic. First, because it is quite new in the EU Regulation, and second because we cannot make a generality and should consider each software one by one. In this episode, we asked directly a Notified Body to tell us exactly how we should view this field and what are the tips or warnings.

So I have invited Dr. Abtin Rad from TÜV SÜD to help us with this exercise. We will discuss with Abtin 3 main topics:

• SaMD classification
• Cybersecurity
• Artificial Intelligence

And you’ll see that there are here a lot of tips for you to follow.

Abtin Rad has 13 years of professional experience as a Biomedical Electrical Engineer with a focus on Software, Cybersecurity, and Artificial Intelligence, as well as medical Imaging. Abtin Rad is a Cybersecurity and Artificial Intelligence Specialist for medical devices, as well as a Lead Auditor for ISO 13485, ISO 9001, MDSAP, and MDD/MDR. Currently, he is leading the digital topics at TÜV SÜD as the focus team manager.

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…

• Dr. Abtin Rad LinkedIn Profile: https://www.linkedin.com/in/dr-ing-abtin-rad-0601b744/
• TÜV SÜD Website : https://www.tuvsud.com/en
• TÜV SÜD Cybersecurity testing: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-testing/physical-testing-of-medical-devices/medical-device-cybersecurity
• TÜV SÜD Medical Devices Job board: https://www.tuvsud.com/en/careers/global-job-opportunities#/medical-devices-healthcare
• TÜV SÜD Software Quality testing: https://www.tuvsud.com/en/services/testing/software-quality-testing
• MDCG 2019-11 Software Qualification and Classification: https://ec.europa.eu/health/sites/default/files/md_topics-interest/docs/md_mdcg_2019_11_guidance_en.pdf
• DRAFT EU Artificial Intelligence Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021PC0206
• ISO/TS 82304-2 :2021: https://www.iso.org/standard/78182.html
• MDCG 2019-16 Cybersecurity for Medical Devices: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_cybersecurity_en.pdf
• IEC/DIS 81001-5-1: https://www.iso.org/standard/76097.html
• IEC TR 60601-4-5 :2021: https://webstore.iec.ch/publication/64703
• Podcast Cybersecurity with Erik Vollebregt: https://podcast.easymedicaldevice.com/67/

The post How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Let’s describe to you the life of a Healthcare industry consultant with Smahan Toughrai.

Within this episode, we will ask the question like:

• Why would we choose a consultant job?
• Should people have a certain skill to be a good consultant?
• Is the salary a good motivation to be a consultant?
• Is it better to work for a small company or a multinational?

If you also have a good or bad experience as a consultant, don’t hesitate to share that with us on the comments.

Smahan Toughraï is a senior consultant at Techfirm, currently working as a quality engineer for a major client in the pharmaceutical industry. Prior to that role, she has been active as an engineering consultant in the life sciences industry (pharma, biotech, hospitals) for the last 6 years at various clients all over Switzerland. Her expertise mainly consists in commissioning/qualification of equipment, cleaning, and process validation, as well as quality and compliance. Smahan has a background in chemistry and chemical engineering graduated from CPE-Lyon (France) and the University of Basel (Switzerland).

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…

• Smahan Toughrai LinkedIn Profile: https://youtu.be/ZrvfoOaSP8s
• Techfirm Website: https://www.techfirm.ch/en/home-en/
• Techfirm LinkedIn Page: https://www.linkedin.com/company/tech’firm/

The post Better to be a Consultant or a Full-time employee? [Lifescience industry] 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.

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After few months of MDR, I proposed TÜV SÜD share with us the most common mistakes they find during their audits. And Martin Witte accepted to summarize some of them. So in this episode, you will hear the TOP 3 issues that are discovered so you can be prepared for it. You will see that some of them are obvious and others are more subtle.

• Administrative work
• Clinical evaluation
• Biocompatibility

And Martin will also provide you some advice on how to be prepared for such an audit. He will also answer a bonus question which is: “Can we invite auditors to a restaurant or offer them a gift?” Don’t miss the links below related to what we discussed.

Martin Witte is Senior Director Strategic Business Development at TÜV SÜD and responsible for the focus topics Active Medical Implants, Cardiovascular, Orthopedic, and Functional Safety/Software. Prior to his current role, Martin worked as a Lead Auditor, Product Specialist in TÜV SÜD from 2014 on, and took over business development activities with his role as the head of the Active Implants business in 2016. Prior to his roles in TÜV SÜD, Martin was a Regulatory Affairs Manager at BIOTRONIK, Berlin focusing on heart rhythm management devices and on MRI safety of such devices. His background is in Biomedical Engineering which he studied in Hamburg.

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…

• Martin Witte LinkedIn Profile: https://www.linkedin.com/in/martin-r-witte/
• TÜV SÜD website: https://www.tuvsud.com/en
• MDCG MDR Codes: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2019_14_mdr_codes_en.pdf
• MDCG IVDR codes: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021-14-guidance-ivdr-codes_en.pdf
• MedBoard: https://www.medboard.com/
• MDCG CEAR: https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_clinical_evaluationtemplate_en.pdf
• CMR Articles: https://www.intertek.com/blog/2020-06-22-mdr/

The post What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD] 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.

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On the agenda for this month Episode we will talk about the latest news and here are few topics that I will present to you:

• Team-NB Position Paper
• Harmonized Standards
• Free ISO standards
• MHRA guidance on Software as Medical Devices
• Training EU MDR
• Green Belt in August
• Notified Bodies situation
• MDCG guidances
• Easy Medical Device Podcast episodes

Don’t miss all the links at the bottom.

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…

• HOT TOPIC
  • Team-NB position paper: Risk-based approach for medical devices exempted from an implant card and information to be supplied to the patients with an implanted device: https://www.team-nb.org/wp-content/uploads/2021/07/Team-NB-PositionPaper-ImplantCard-202107020.pdf
  • Harmonized Standard IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021D1195
  • Harmonized Standards MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021D1182
  • Episode 92 – How to prepare MDR audit with Martin Witte https://www.youtube.com/watch?v=Oa7jwL-HxgI
  • EU Common list of Covid-19 Rapid antigen test: https://ec.europa.eu/health/security/crisis-management/twg_covid-19_diagnostic_tests_en
  • Free ISO standards for Covid-19: https://www.iso.org/covid19?fbclid=IwAR1bUVGOr2Tv84Og4fiI0wsSCQi9XKD-Iw-j5QBifNZTTWKVluW1Kv8vqyw
  • MHRA: Guidance on Medical Device Stand-alone software including apps: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/999908/Software_flow_chart_Ed_1-08b-IVD.pdf
  • Green Belt Certification 14th Edition: https://school.easymedicaldevice.com/course/gb14/
• NOTIFIED BODIES
  • EU MDR Notified Body: Eurofins Product Testing S.r.l: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=313745&version_no=4
  • EU MDR Notified Body: KIWA CERMET S.P.A.: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=313661&version_no=10
• GUIDANCE AND STANDARDS
  • MDCG 2021-20 – Instructions on generating CIV-IF for MDR Clinical Investigation: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-20_en.pdf
  • MDCG 2021-15 – Conformity assessment body. Application form applying for NB under MDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-15_en.docx
  • MDCG 2021-16 – Conformity assessment body. Application form applying for NB under IVDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-16_en.docx
  • MDCG 2021-17 – Conformity assessment body. Applied-for scope MDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-17_en.docx
  • MDCG 2021-18 – Conformity assessment body. Applied-for scope IVDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-18_en.docx
  • MDCG 2021-19 Guidance not integration of the udi within an organization Quality Management System: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_2021-19_en.pdf
  • MDCG 2021-14 Explanatory note on IVDR codes: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021-14-guidance-ivdr-codes_en.pdf
  • MDCG 2021-13 rev 1 : Q&A EUDAMED registration: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021-13_q-a-actor_registr_eudamed_en.pdf
• EASY MEDICAL DEVICE activities
  • Episode 136 – How to interpret the first Expert Panel Opinion? Bassil Akra https://podcast.easymedicaldevice.com/136/
  • Episode 137 – System and Procedure Pack the RETURN with Erik Vollebregt https://podcast.easymedicaldevice.com/137/
  • Episode 138 – How to implement Vigilance Reporting for MDR and IVDR https://podcast.easymedicaldevice.com/138/

The post Medical Device News – August 2021 Regulatory Update [MDR & IVDR] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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