https://www.youtube.com/embed/M0XRSo4Ts1U?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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.

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.

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…

• Leon Linkedin Profile: https://www.linkedin.com/in/leondoorn

• Will the MDR improve regulatory oversight of AI solutions?: https://www.aidence.com/articles/mdr-oversight-of-ai-solutions/

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

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

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

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.

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).

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…

• Liat Nadel Linkedin Profile: https://bit.ly/3hX3nW4

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

https://www.youtube.com/embed/Orw5xqcOimU?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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

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

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…

• UK Rep from Jan 1st, 2021: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market-from-1-january-2021

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

• NANDO EU MDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

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

• How to register a Medical Device in Mexico https://podcast.easymedicaldevice.com/106/

The post Medical Device News – January 2021 Update (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/wrfkXxlxuJI?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 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

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.

• Episode 100: https://podcast.easymedicaldevice.com/100/

The post How Easy Medical Device can help you? (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/5-aFIL6HI0g?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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.

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.

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…

• Martin Witte LinkedIn: https://www.linkedin.com/in/martin-r-witte/

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