Easy Medical Device Podcast

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If you are transitioning from the EU MDD 93/42/EC or 90/385/EEC to the EU MDR 2017/745 or from the IVDD 98/79/EC to the IVDR 2017/745, then you have to be careful with Significant Changes.

In this episode, I’ve asked Martin Witte from TÜV SÜD to give us the point of view of Notified Bodies on Significant changes. When we should consider them, what are the best practices, what to do when we deal with a significant change, and what are the consequences if we are not following the regulation.

So this will be an excellent episode to help you prepare your procedures for significant changes and understand the risks.

Who is Martin Witte?

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 in Biomedical Engineering which he studied in Hamburg.

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…

Link

• Martin Witte LinkedIn: https://www.linkedin.com/in/martin-r-witte/
• TÜV SÜD Notified Body page: https://www.tuvsud.com/en
• TÜV SÜD application form: https://bit.ly/3i2Ahnl
• Episode 92- Prepare your MDR audit: https://podcast.easymedicaldevice.com/92
• MDCG 2020-3: Significant changes for your Medical Device: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_guidance_significant_changes_annexes_en.pdf

The post How to deal with Significant Changes within MDR & IVDR with Martin Witte appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Martin Witte from TÜV SÜD will help us to understand the significant changes to your devices and the consequence of it for your CE Certificate. You will have to listen carefully if you are selling medical devices on the EU market after May 26th, 2021 under your EU MDD certificate. The post How to deal with Significant Changes within MDR & IVDR with Martin Witte appeared first on Medical Device made Easy Podcast.

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The registration of Medical Devices is always different and this time we will explain to you how you can do that in Mexico.

For that I have invited to the Medical Device made Easy Podcast, Josué Garza from Insumos para la Salud or IPS.

Josué will explain to us the pathways needed to register your Medical Devices in Mexico. He will also give you some advice regarding the Ministry of health.

Who is Josué Garza?

Josué Garza is the Director of Business Development & Operations at Insumos para la Salud (IPS), a regulatory affairs consulting firm helping medical device manufacturers and distributors obtain market access in Mexico.

Josué has over 10 years of experience working with the private sector, government and nonprofit organizations. Before joining IPS, he took leadership positions in the International Republican Institute, Consulate General of Mexico in Atlanta, Premier Destination Services and the Institutional Revolutionary Party.

Josue has expertise in managing projects at the municipal, state and national levels, participating in public policy initiatives, and developing strategies through team-centered processes.

Today, he continues to influence the growth of IPS by helping businesses from around the world thrive in Mexico and improve access to the best health products for Mexicans.

Josué holds a BA in International Relations from Universidad Iberoamericana. He spends most of his time in Chicago and Mexico City.

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

Links

• Josué Garza LinkedIn profile: https://www.linkedin.com/in/josuegarza/
• IPS website: https://www.insumosparasalud.com/
• COFEPRIS website: https://www.gob.mx/cofepris
• Mexican Association of Medical Device Innovative Industries (AMID): https://amid.org.mx/

The post How to register a Medical Device in Mexico? [Josué Garza] 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.

You maybe know how to register your devices in Europe or USA now. But let's discover how we can do that in Mexico with Josué Garza from IPS or Insumos para la salud. You'll learn the 3 pathways to do that. The post How to register a Medical Device in Mexico? [Josué Garza] appeared first on Medical Device made Easy Podcast.

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In this monthly review of Medical Device News, we will see what happened this November 2020 for the Medical Device Industry.

During this review, we will check some topics like:

• Eudamed
• Quality engine
• Brexit and UK responsible Person
• TEAM NB Position paper with some proposals
• Job Opportunities in EU and the US
• Greenlight Guru event
• TOPRA Award: Who is the winner
• Notified Body situation
• Guidance
• 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 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, Podcast, Online courses…

Links from the Video

HOT TOPICS

• EUDAMED Actor module FAQ: https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/md_actor_module_q-a_en.pdf
• Link EUDAMED Registration: https://webgate.ec.europa.eu/eudamed
• Quality Engine: https://quality-engine.com/
• Easy Medical Device UK Responsible Person: https://easymedicaldevice.com/uk-responsible-person/
• Brexit communication: https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021
• TEAM-NB Position paper: https://www.team-nb.org/wp-content/uploads/2020/11/Team-NB-PositionPaper-Team-NB-consideration-paper-on-IVDR-Date-of-Application.pdf
• Job ELEMED: https://www.elemed.eu/vacancies/
• Job Life Science People: https://www.lifesciencepeople.co.uk/jobs
• Job The Anthony Michael Group: https://www.theanthonymichaelgroup.com/opportunities/
• TOPRA Award Ceremony: https://www.youtube.com/watch?v=vKJFEFCrrEg
• Greenlight Guru Virtual Event: https://2021md.greenlight.guru/?sc=XX1H2oPX&ac=gJxS6x7K
• Green Belt Certificate: https://school.easymedicaldevice.com/gb

NOTIFIED BODIES

• UDEM Adriatic: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=NANDO_INPUT_232844

GUIDANCES

• Agenda for MDCG meeting: https://ec.europa.eu/health/sites/health/files/md_dialogue/docs/md_events_2021_en.pdf

• MDCG 2020-16 Classification rules for IVDR: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_guidance_classification_ivd-md_en.pdf

PODCAST EPISODES

• Episode 100 – Last 2 years story: https://podcast.easymedicaldevice.com/100/
• Episode 101: Common Specifications with Stefan Bolleininger: https://podcast.easymedicaldevice.com/101/
• Episode 102: Expert Panels with Bassil Akra: https://podcast.easymedicaldevice.com/102/
• Episode 103: Training benefits with SOFMEDICA Team: https://podcast.easymedicaldevice.com/103/
• Episode 104: Notified Body accreditation with Caroline Dore Geraghty: https://podcast.easymedicaldevice.com/104/

The post Medical Device News: What happened in November 2020? 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 November update is providing a lot of information on what you should not miss. We will talk Brexit, Eudamed, Jobs, Training... A lot of topic to help you stay up-to-date. The post Medical Device News: What happened in November 2020? appeared first on Medical Device made Easy Podcast.

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We talk a lot about Manufacturers that are under pressure because they cannot find a Notified Body, but today we will also talk about the pressure on Notified Bodies.

Caroline Dore Geraghty, Director of Medical Devices at NSAI is my guest and she will tell us more about the process for Notified Bodies to get accredited. NSAI is an Irish Notified Body and it received its accreditation for EU MDR and can now help its customer.

We will talk about:

• The process to get accredited
• The possibility to certify the company for EU MDD 93/42/EC
• The action of the Notified Bodies during the transition period after the date of application (May 26th, 2021)
• The different services that NSAI can offer

NSAI is also looking for auditors so don’t hesitate to contact NSAI if you are interested.

Who is Caroline Dore Geraghty?

Dr. Caroline Dore Geraghty is the Director of medical devices and Head of the notified body. Caroline graduated from the Royal College of Surgeons in Ireland as a medical doctor in 2002 and worked clinically for 12 years.

She holds a masters of science degree in allergy and a diploma in dermatology.

Caroline was head of the clinical team in NSAI for 4 years prior to her promotion to director of the medical devices department.

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 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

• Caroline Dore Geraghty LinkedIn: https://www.linkedin.com/in/caroline-dore-geraghty-33117452/
• NSAI website: https://www.nsai.ie/certification/medical-devices/
• Join NSAI: https://www.nsai.ie/about/work-with-us/
• Episode 92 – Notified Body audit: https://podcast.easymedicaldevice.com/92/

The post Is it Easy for a Notified Body to get EU MDR accredited? 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 episode, we will hear the journey of a Notified Body to get EU MDR accredited. We hope this will help you to understand how difficult it is and why you should be patient with your Notified Body. The post Is it Easy for a Notified Body to get EU MDR accredited? appeared first on Medical Device made Easy Podcast.

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I had the chance to train many people to EU MDR and I am always proud to see them implementing what they have learned. And today I want to tell you the story of the company Sofmedica.

This is an Importer and Distributor in Europe and they have participated in the Green Belt Certificate. This is the training on EU MDR that Easy Medical Device is proposing. I have interviewed 3 of their QA RA employees with Cristina Miroescu, Rodica Paslaru, and Katerina Pappa.

Training is something important. As Katerina Pappa said, reading the text is not sufficient, you have to test your knowledge and check that you have really well understood. So for those that are hesitating to take training, this podcast episode will help you understand the benefit of such investment. If you also want to participate in the Green Belt Certificate, please check the next session at https://school.easymedicaldevice.com/gb/

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

Links

• Cristina Miroescu Linkedin: https://www.linkedin.com/in/cristina-miroescu-4255a6164/
• Rodica Paslaru Linkedin: https://www.linkedin.com/in/rodica-paslaru-22a28726/
• Katerina Pappa Linkedin: https://www.linkedin.com/in/katerina-pappa-27233967/
• Sofmedica website: https://www.sofmedica.com
• Download Presentation: https://mailchi.mp/easymedicaldevice/sofmedica-presentation

The post How a Quality & Regulatory training can help you? [Sofmedica] 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 episode, we will tell you why this is important to invest on trainings for your employees. I have invited a company that participated to the Green Belt Certificate and I asked them to tell us what they have implemented after taking this training. The post How a Quality & Regulatory training can help you? [Sofmedica] appeared first on Medical Device made Easy Podcast.