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

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.

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.

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…

• Josué Garza LinkedIn profile: https://www.linkedin.com/in/josuegarza/

The post How to register a Medical Device in Mexico? [Josué Garza] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/nB8PMi3LXNE?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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

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…

HOT TOPICS

• EUDAMED Actor module FAQ: https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/md_actor_module_q-a_en.pdf

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/

The post Medical Device News: What happened in November 2020? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/DLym6Px7OyU?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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

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

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.

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…

• Caroline Dore Geraghty LinkedIn: https://www.linkedin.com/in/caroline-dore-geraghty-33117452/

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

https://www.youtube.com/embed/jVzDa0MBsdA?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

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/

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…

• Cristina Miroescu Linkedin: https://www.linkedin.com/in/cristina-miroescu-4255a6164/

The post How a Quality & Regulatory training can help you? [Sofmedica] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/4NS7WjmetgM?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The EU MDR 2017/745 is increasing the requirements for Clinical Evaluations. In this episode, I will be with Dr. Bassil Akra from QUNIQUE and we will explain to you the different levels of reviews that exist and specifically about the Expert Panel.

You would maybe ask “What is this?”.

Don’t worry, we will explain to you and even provide you with more information also on some voluntary consultation that this group can provide.

In case you need some support for your Clinical Evaluation Reports, UK responsible process, Technical File review, Training for EU MDR, don’t hesitate to contact us at [email protected] We can guide you on this process.

Dr. Bassil Akra, Co-owner and CEO of QUNIQUE Group has a background in research, development, regulatory approval, and quality management of medical devices.

Within his role at TÜV SÜD, Dr. Akra was a member of various Medical Device Regulation (MDR) European task forces, to help with the interpretation of the new legislation towards a smooth transition into May of 2020.

In addition to his work as a senior field expert for TÜV SÜD, Dr. Akra presents worldwide on the European requirements and was involved in the development of many guidance documents and standards.

In his new role as Co-owner and CEO of QUNIQUE Group, he will now be also able to support Medical Device manufacturers through consulting and training.

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…

• Bassil Akra LinkedIn Profile: https://www.linkedin.com/in/bassil-akra-2388b84b/

The post Do you need an Expert Panel for your Medical Devices? [Bassil Akra] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi