Easy Medical Device Podcast

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PMS is one of the processes that is changing due to EU MDR and I wanted to come back to it with Ivan Perez Chamorro from MedBoard.

MedBoard is a solution that helps you with your Regulatory Intelligence. And Ivan is trying to make the life of the companies easier by providing some tools. In this episode, Ivan will first explain to us what is PMS and how this is working. And then how a digital solution can help.

Don’t hesitate to try MedBoard as this is free for the first 3 weeks.

Who is Ivan Perez Chamorro?

Ivan Perez Chamorro is CEO and Founder of MedBoard, a technology company that organises medical technology information and data, makes it fast accessible to manufacturers and key stakeholders, and it is integrated with breakthrough tools as the Vigilance automation. MedBoard is made up of leading engineers, scientist and medical professionals. This big data platform covers from Regulatory, to Clinical, Market and Technical.

Ivan has both strong science and business background, he holds a degree and MSc in Physics from Universidad de Salamanca, and an MBA from IE Business School. Ivan is very active in medical device industry, and he is also part of the TOPRA MedTech SPIN.

After having a chronic sports injury while playing basketball, and spending many years in rehabilitation, he decided after physics graduation to work in the medical devices industry. Ivan has lived in different countries and likes travelling, painting, and adventure sports, and has special interest in innovation, entrepreneurship, and technology. MedBoard is not the first project, and Ivan has have a number of entrepreneurship projects in the past, in the medical and outside of medical devices industry.

Before Medboard, Ivan had worked for many years within the industry, as an employee of leading medical companies and as a consultant in the areas of product and business development, regulations, and strategy, from operational roles to advising technical and top management. He has broad experience with different types and classes of medical devices and combination products, supporting a variety of organization models, from start-ups to large corporations.

Who is Monir El Azzouzi?

TextMonir 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…

Link

• Ivan’s LinkedIn Profile: https://www.linkedin.com/in/ivan-perez-chamorro-804b0b22/
• MedBoard link: http://www.medboardco.com/your-medboard/news-feed/
• Podcast episode PMS: https://podcast.easymedicaldevice.com/41/

The post How to perform your PMS more easily with Ivan Perez Chamorro? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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PMS is an action that take some hours to perform. But with all the information generated, it get worse and worse. So I have invited Ivan Perez Chamorro, the Founder and CEO of Medboard to help us understand how we can love to perform PMS within our companies. Medboard has the solution. The post How to perform your PMS more easily with Ivan Perez Chamorro? appeared first on Medical Device made Easy Podcast.

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Artificial Intelligence. This is the topic of today’s podcast episode. We will help you understand how to place AI Software as a Medical Device in the EU Market with the new EU MDR 2017/745.

For that, I have with me Leon Doorn from Aidence who is explaining to us its journey to get EU MDR 2017/745 certified. You will first understand what is really artificial intelligence, then we will talk about the classification of SaMD or Software as Medical Devices.

Leon will also tell us what went well and what was really a struggle for him. We will also talk about the Notified Body support. So if you are a company that develops SaMD or AI software then this episode is for you.

Don’t hesitate to contact Easy Medical Device ([email protected]) if you have some SaMD project. We can help you with it.

Who is Leon Doorn?

Leon is responsible for Regulatory Affairs within Aidence, a scale up company, who are developing AI solutions to detect abnormalities in imaging. He is working for over 12 years in the medical industry, within the quality and regulatory field and has gained his specific knowledge on Artificial Intelligence while working at Aidence.

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 and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

• Leon Linkedin Profile: https://www.linkedin.com/in/leondoorn
• Email: [email protected]
• Podcast episode Cybersecurity: https://podcast.easymedicaldevice.com/67/

Blog articles:

• Will the MDR improve regulatory oversight of AI solutions?: https://www.aidence.com/articles/mdr-oversight-of-ai-solutions/
• Regulations are rapidly evolving, but do they match technology?: https://www.aidence.com/articles/regulations-ai-medical-device/

Product page:

• Veye Chest, your AI lung nodule management solution: https://www.aidence.com/veye-chest/
• Veye Reporting, your interactive lung nodule reporting solution: https://www.aidence.com/veye-reporting/

The post How to get the MDR certification for Artificial Intelligence Softwares? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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The new EU MDR is now taking into account dangerous Software as a Medical Device SAMD. In this episode we will talk specifically about Artificial Intelligence Software. How to make them safe and efficient to be EU MDR certified? Listen to know. The post How to get the MDR certification for Artificial Intelligence Softwares? appeared first on Medical Device made Easy Podcast.

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Registration of products in different countries is always a Challenge. And for Israel, this is the same.

I have invited Liat Nadel from L.S. Marketing & Registration to help us understand the situation and how to succeed in the registration process. We will talk also about the possibility to use registrations already done in Europe and the US to be able to accelerate the process.

Liat will also share with us the services that she will provide to be able to support you on this project.

Who is Liat Nadel?

Liat holds a  BA  Degree in Biologics  , Master of Law/ degree from Bar Ilan University Israel / a Jurist .  A multidisciplinary/ experienced professional in the medical device industry & has a rich background & in- depth knowledge, over 20 + years in Israel & worldwide.

Focus:  Regulatory Affairs, QMS,  Import-export, Business Development, Law.    Liat has managed RA departments in various medical devices companies in Israel such as Tzamal Medical Group, Omrix Biopharmaceuticals Ltd. / today J& J.

Liat also has vast experience in foreign relations (she speaks German, English, French Hebrew, Arabic).

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

• Liat Nadel Linkedin Profile: https://bit.ly/3hX3nW4
• L.S. Marketing & Registration: http://www.ls-amarandmore.com/

The post How to register a Medical Device in Israel? (Liat Nadel) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Liat Nadel is the CEO of L.S. Marketing & Registration. She will help us to understand the context for the registration of Medical Devices in Israel. The post How to register a Medical Device in Israel? (Liat Nadel) appeared first on Medical Device made Easy Podcast.

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HAPPY NEW YEAR 2021 and all my best wishes to you and your family.

Within this Medical Device News monthly episode of the podcast, we are reviewing the situation on:

• Brexit and the need for UK Responsible person
• Swixit and Turkxit
• EUDAMED and PRRC information made public
• Team NB position papers
• Training – Notified Body situation
• UK Approved Body situation
• MDCG guidance
• Podcast review

Don’t forget that Easy Medical Device can be your UK Responsible Person or also your EU REP contact us at [email protected]

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…

LinksHOT TOPICS.

• UK Rep from Jan 1st, 2021: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market-from-1-january-2021
• Easy Medical Device UK Rep: https://easymedicaldevice.com/uk-responsible-person/
• Erik Vollebregt Brexit post: https://medicaldeviceslegal.com/2020/12/28/the-brexit-deal-whats-not-in-it-for-the-medical-devices-industry/
• Survey Swixit Turkxit: https://www.linkedin.com/posts/melazzouzi_medicaldevices-easymedicaldevice-regulatoryaffairs-activity-6751203793725116416-lPjR
• Rolling Plan: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_rolling-plan_en.pdf
• EUDAMED PRRC question: https://www.linkedin.com/posts/ronald-boumans-34790055_eudamed-prrc-gdpr-activity-6745368549667155969-RzNv
• TEAM-NB Drug-Device Position Paper: https://www.team-nb.org/wp-content/uploads/2020/12/Team-NBPosition-Paper-Art117SubChangeLifeCycleMngt-202012.pdf
• MDCG 2020-3 on Significant changes: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_guidance_significant_changes_annexes_en.pdf

TRAINING:

• Green Belt Certificate: https://school.easymedicaldevice.com/gb/

NOTIFIED BODIES:

• NANDO EU MDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
• TEAM NB Expiring certificates: https://www.team-nb.org/wp-content/uploads/2020/12/Team-NB-PositionPaper-ExpiringCertificates-20201215.pdf
• Survey: EU MDR & IVDR postponement: https://www.linkedin.com/posts/melazzouzi_there-were-a-lot-of-requests-related-to-the-activity-6751181775264890880-FWOK
• The UK approved bodies: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies

GUIDANCES:

• MDCG guidance Lenses 2020-18: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_18_en.pdf
• Ongoing guidance: https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_ongoing_guidancedocs_en.pdf

PODCAST:

• How to register a Medical Device in Mexico https://podcast.easymedicaldevice.com/106/
• How to deal with Significant Changes with Martin Witte https://podcast.easymedicaldevice.com/107/
• How Easy Medical Device can help you? https://podcast.easymedicaldevice.com/108/

The post Medical Device News – January 2021 Update (Monir El Azzouzi) 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 first episode of 2021 we provide you an update of the Medical Device Regulation situation. We will talk about Brexit, Swixit, Turkxit, MDCG, Notified Bodies, Approved Bodies, Trainings, Podcast... A lot to cover. The post Medical Device News – January 2021 Update (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast.

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In this episode of the Medical Device made Easy Podcast, I will share with you the progress of the Easy Medical Device project.

I hope this will be helping the medical device community and if you need more support, please ask me. I am really here to help you. We will talk about:

• Podcast
• Training
• Consulting
• Coaching
• Authorized Representatives
• Easy Medical Expert

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…

Lastly he also created Easy Medical Device UK to be the UK Authorized Representative for its customers.

Links

• Episode 100: https://podcast.easymedicaldevice.com/100/
• Green Belt Certificate: https://school.easymedicaldevice.com/gb/

The post How Easy Medical Device can help you? (Monir El Azzouzi) 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 is the last episode of 2020 and I wanted to share with you the progress of the Easy Medical Device project. I will also tell you the next steps that I will try to achieve. Let me know how I can help you? The post How Easy Medical Device can help you? (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast.