Easy Medical Device Podcast

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In this episode of the podcast, I wanted an expert to answer the question about IP related to Medical Devices. A lot of people are willing to understand how intellectual property works when for example:

• We have a Private Labeling Business
• When we buy a product already designed by another company but place it on the market under your name?
• When we want to mention “MADE IN” and a different country than where the product comes from…

Stephan Carter from UK is my guest today and he manages this type of situation for you. You will hear on this episode some advice that would really be beneficial to your business.

Who is Stephen Carter?

Stephen is a UK and European patent attorney and founder of The Intellectual Property Works. He is recognized by ‘IAM Strategy 300’ as one of the world’s leading IP strategists and is now focused on working with ambitious MedTech start-ups and SMEs to protect their innovations, helping them to succeed so they can make a positive impact in the world.

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

• Stephen Carter LinkedIn Profile: https://www.linkedin.com/in/stephenjcarter/
• The Intellectual Property Works: https://theintellectualpropertyworks.co.uk/
• UK MHRA Virtual Manufacturer: https://www.gov.uk/government/publications/medical-devices-virtual-manufacturing-replaces-own-brand-labelling/virtual-manufacturing-of-medical-devices
• “Made in” USA: https://www.sgrlaw.com/when-is-it-okay-to-label-my-product-as-made-in-usa/

The post How Intellectual Property is linked to the Medical Device Regulation? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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In the case you are placing your brand trademark on a product, or if you buy a product designed by another company... then you need to understand the rules related to Intellectual properties. This episode with Stephen Carter will be a masterclass about Intellectual Property. The post How Intellectual Property is linked to the Medical Device Regulation? appeared first on Medical Device made Easy Podcast.

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Clinical Investigation is one of the toughest process within the EU MDR 2017/745. If you have to perform one for your Medical Devices then it can be a long and expensive process.

In this episode, Helene Quie from Qmed Consulting, will help us understand how to perform it in a good way. This episode will answer some of the questions you have about Clinical Investigation and we hope this will make more clarity for you.

Some of the questions answered are:

• Which products do need a clinical investigation?
• Can we test our products on our employees without a clinical investigation?
• How long does it take and how much does it cost?

Don’t hesitate to go below check the links on the different guidance.

Who is Helene Quie?

CEO at Qmed-consulting – experts in creating value-based documentation for innovative medical devices getting access to the markets through strong and honest partnerships with our clients.

It is my vision to enable better health through close collaborations with large established or newly started medical device manufacturers, small venture based innovative companies, venture funds, notified bodies, hospital, doctors and nurses within a wide range of medical device products and concepts from high-risk complex products such as heart valves with biological tissue to lower risk class products such as dental care products.

I believe that we through our trusted partners and colleagues can change the treatment of sick patients – making sure frontier products reach the patients and end-users, saving patient’s lives.

Together with the Qmed team, I have provided advice and/or operational services for several clients since 2006 within clinical and regulatory affairs, quality management, reimbursement, and health economics and market access with presence through our Qmed team and trusted partners in Europe, US, Canada, India, and Australia. 

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…

Link

• Helene Quie Linkedin Profile: https://www.linkedin.com/in/helene-quie-863a323/
• Qmed Consulting: https://www.qmed-consulting.com/
• MDCG 2021-8. https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-8_en.pdf
• MDCG 2021-6: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-6_en.pdf
• MDCG 2020-10: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020-10-1_guidance_safety_reporting_en.pdf

The post How to perform a good Clinical Investigation with Helene Quie appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Clinical Investigation is not really an easy process. So it can be important for your to understand what are the requirements and get some details about time and cost. Helene Quie from Qmed Consulting which is also a CRO will help us learn more about this process required by EU MDR. The post How to perform a good Clinical Investigation with Helene Quie appeared first on Medical Device made Easy Podcast.

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

We talked a lot about the regulatory requirements for your Medical Devices. Now let’s talk about something more technical which is the Biological Evaluation following ISO 10993-1 or also called Biocompatibility.

This is something that is key for the Medical Device Manufacturers but it is also not well understood. So Ana Luiza Cassin Duz, a Clinical Specialist for Medical Devices is helping us. She will answer all my questions on Biological Evaluation and I am sure there is something that will surprise you.

Don’t hesitate to ask your questions in the comments.

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

The post How to perform a Biological Evaluation for your Medical Device? 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.

This podcast episode is really important as this answers some of the questions that a lot of my customers are asking. So I hope this will help you to understand why this is important to perform a Biological Evaluation or Biocompatibility for your finished product. The post How to perform a Biological Evaluation for your Medical Device? appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/fq45NSs4Mt4?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Ok, this month the EU MDR is LIVE so we will talk about that. The date of application for EU MDR 2017/745 was May 26th, 2021 and there is a lot of information that I will share with you.

We will talk about

• EU MDD bye bye party
• Webinars
• EU MDR impact on other countries
• Swixit
• Turkxit
• IVDR 2017/746
• Notified Body Situation
• MDCG guidance
• IMDRF guidance
• Podcast
• Live session
• Erik Vollebregt book

Links from the Video

HOT TOPICS

• Portugal Inframed: https://www.infarmed.pt/web/infarmed/noticias/-/journal_content/56/15786/4404079
• Italy: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=5499
• Spain AEMPS: https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2021-productossanitarios/hoy-comienza-a-aplicarse-en-la-union-europea-el-nuevo-reglamento-de-productos-sanitarios/
• Belgium AFMPS: https://www.afmps.be/fr/news/dispositifs_medicaux_reglement_2017745_applicable_des_aujourdhui
• France Webinar ANSM: 2h French Webinar explanation EU MDR: https://ansm.sante.fr/evenements/reunion-dinformation-sur-le-nouveau-reglement-europeen-relatif-aux-dispositifs-medicaux-1
• DG Health 2h Webinar for Patients – Safe and performant Medical Devices for all Webinar for Patients – Safe and performant Medical Devices for all
• UDI Helpdesk: https://eu-udi.zendesk.com/hc/en-150
• EMDN Nomenclature: https://webgate.ec.europa.eu/dyna2/emdn/
• Ireland: HPRA new EU Device Legislation Information Pack http://www.hpra.ie/docs/default-source/default-document-library/hpra-eu-device-legislation-info-pack.pdf?sfvrsn=0
• Australia: Consultation to change MD classification following EU MDR publication: https://www.tga.gov.au/medical-devices-reforms-reclassification-certain-medical-devices
• JAMS Report: https://www.camd-europe.eu/wp-content/uploads/2021/05/JAMS-Layman-version-final-report-2020.pdf

SWIXIT

• Revision of the Medical Device Legislation: https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html
• New Regulation applicable to MD as of May 26th, 2021: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/neue-regulierug-mep-26-05-2021.html
• New MedOD: https://www.fedlex.admin.ch/eli/cc/2020/552/en
• Swiss SRN for Swiss Manufacturers, Authorised Representatives and Importer upon demand. https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.html
• Notification of Medical Devices: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/meldung-medizinprodukten.html

TURKXIT

• Team NB Letter to MDCG: https://www.team-nb.org/wp-content/uploads/2021/05/MDCG-Update_EU-Turkey-Customs-Union-Medical-Devices.pdf

IVDR 2017/746

• IVDR: TEAM NB – CA for class D devices https://www.team-nb.org/wp-content/uploads/2021/05/Team-NB-PositionPaper-ClassD-20210519-V4.4.pdf

Standard and Guidance

• MDCG 2021-09 – MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers
• MDCG 2020-18: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020_18_en.pdf
• MDCG 2021-08 Clinical investigation application/notification documents https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-8_en.pdf
• MDCG 2021-7 Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-7_en.pdf
• IMDRF – PMCF Studies: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-210325-wng65.pdf

EASY MEDICAL DEVICE

• FDA: Is the Emergency Use Authorization worth it? Michelle Lott https://podcast.easymedicaldevice.com/127/
• MDR is coming – Brace yourself Erik Vollebregt https://podcast.easymedicaldevice.com/128/
• EU MDR Survey: What is the industry opinion? Catherine Higginson https://podcast.easymedicaldevice.com/129/
• LinkedIn Live – All about PMCF with Cesare Magri https://www.youtube.com/watch?v=kq_c_hFhKeE
• Erik Vollebregt Book -The Enriched MDR and IVDR: https://medicaldeviceslegal.com/2021/05/24/the-enriched-mdr-and-ivdr-finally-available/

The post Medical Device News – June 2021 Update [EU MDR Date of Application] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Medical Device News June 2021 Update is providing you all the last updates. This IS the episode of the EU MDR date of application. A lot of news provided. The post Medical Device News – June 2021 Update [EU MDR Date of Application] appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/tZNAV8nTIgQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Last year we had reviewed the result of the EU MDR Survey made by Climedo and this year we check the difference. Do you think that there will be a big change?

Climedo has decided to ask questions related to the EU MDR but also to the context due to Coronavirus. So we are now looking at the result and you’ll see that there are some changes. But still the same on some of the most important topics.

Check below for the link on the last survey and this year’s one.

Who is Catherine Higginson?

Catherine started her career in the SaaS field in Corporate Communications for a B2B online language training company where she managed the company’s global marketing and PR activities. After almost four years, she switched to strategy consulting firm Oliver Wyman to help drive the company’s digital marketing and employer branding mission within Europe. In 2019, she joined Climedo Health, a software company that helps MedTech companies collect clinical data on their medical devices with the help of cloud-based solutions. As a bit of a “newbie” to the healthcare sector, she has enjoyed the steep learning curve offered by the startup world and creates regular content to help educate MedTech companies on matters such as electronic data capture and the EU MDR. She also carries out market research to assess the state of the industry in terms of MDR preparation and costs. Catherine studied Modern Languages (French and Spanish) at Newcastle University, followed by a Masters’s degree in Management at Warwick Business School.

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

Links

• Catherine Higginson LinkedIn Profile: https://www.linkedin.com/in/catherine-higginson/
• Climedo Website: https://climedo.de/en/
• Episode 98 – Cost of EU MDR: https://podcast.easymedicaldevice.com/98/
• 2020 Survey result – Cost of EU MDR: http://bit.ly/EU-MDR-Costs
• 2021 Survey result: https://climedo.de/en/press/eumdr-survey-results-2021/

The post EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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EU MDR is starting tomorrow and we wanted to check the situation for Economic Operators. We had already interviewed Catherine on the previous survey release. This time we do a follow-up The post EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson] appeared first on Medical Device made Easy Podcast.