https://www.youtube.com/embed/M6SDznPQI08?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Software as a Medical Device is really a difficult topic. First, because it is quite new in the EU Regulation, and second because we cannot make a generality and should consider each software one by one. In this episode, we asked directly a Notified Body to tell us exactly how we should view this field and what are the tips or warnings.

So I have invited Dr. Abtin Rad from TÜV SÜD to help us with this exercise. We will discuss with Abtin 3 main topics:

• SaMD classification

And you’ll see that there are here a lot of tips for you to follow.

Abtin Rad has 13 years of professional experience as a Biomedical Electrical Engineer with a focus on Software, Cybersecurity, and Artificial Intelligence, as well as medical Imaging. Abtin Rad is a Cybersecurity and Artificial Intelligence Specialist for medical devices, as well as a Lead Auditor for ISO 13485, ISO 9001, MDSAP, and MDD/MDR. Currently, he is leading the digital topics at TÜV SÜD as the focus team manager.

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, podcasts, online courses…

• Dr. Abtin Rad LinkedIn Profile: https://www.linkedin.com/in/dr-ing-abtin-rad-0601b744/

The post How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/ZrvfoOaSP8s?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Let’s describe to you the life of a Healthcare industry consultant with Smahan Toughrai.

Within this episode, we will ask the question like:

• Why would we choose a consultant job?

If you also have a good or bad experience as a consultant, don’t hesitate to share that with us on the comments.

Smahan Toughraï is a senior consultant at Techfirm, currently working as a quality engineer for a major client in the pharmaceutical industry. Prior to that role, she has been active as an engineering consultant in the life sciences industry (pharma, biotech, hospitals) for the last 6 years at various clients all over Switzerland. Her expertise mainly consists in commissioning/qualification of equipment, cleaning, and process validation, as well as quality and compliance. Smahan has a background in chemistry and chemical engineering graduated from CPE-Lyon (France) and the University of Basel (Switzerland).

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, podcasts, Online courses…

• Smahan Toughrai LinkedIn Profile: https://youtu.be/ZrvfoOaSP8s

The post Better to be a Consultant or a Full-time employee? [Lifescience industry] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/B4iA03eOLAw?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

After few months of MDR, I proposed TÜV SÜD share with us the most common mistakes they find during their audits. And Martin Witte accepted to summarize some of them. So in this episode, you will hear the TOP 3 issues that are discovered so you can be prepared for it. You will see that some of them are obvious and others are more subtle.

• Administrative work

And Martin will also provide you some advice on how to be prepared for such an audit. He will also answer a bonus question which is: “Can we invite auditors to a restaurant or offer them a gift?” Don’t miss the links below related to what we discussed.

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

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

The post What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/_AhV5CWgL1s?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

On the agenda for this month Episode we will talk about the latest news and here are few topics that I will present to you:

• Team-NB Position Paper

Don’t miss all the links at the bottom.

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, podcasts, online courses…

• HOT TOPIC
  • Team-NB position paper: Risk-based approach for medical devices exempted from an implant card and information to be supplied to the patients with an implanted device: https://www.team-nb.org/wp-content/uploads/2021/07/Team-NB-PositionPaper-ImplantCard-202107020.pdf

• Harmonized Standard IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021D1195

• Harmonized Standards MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021D1182

• Episode 92 – How to prepare MDR audit with Martin Witte https://www.youtube.com/watch?v=Oa7jwL-HxgI

• EU Common list of Covid-19 Rapid antigen test: https://ec.europa.eu/health/security/crisis-management/twg_covid-19_diagnostic_tests_en

• Free ISO standards for Covid-19: https://www.iso.org/covid19?fbclid=IwAR1bUVGOr2Tv84Og4fiI0wsSCQi9XKD-Iw-j5QBifNZTTWKVluW1Kv8vqyw

• MHRA: Guidance on Medical Device Stand-alone software including apps: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/999908/Software_flow_chart_Ed_1-08b-IVD.pdf

• EU MDR Notified Body: KIWA CERMET S.P.A.: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=313661&version_no=10

The post Medical Device News – August 2021 Regulatory Update [MDR & IVDR] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/4bboTY74eAI?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Within this Masterclass, I will explain to you how to implement a vigilance reporting system with all the links for all the documents we talk about.

Vigilance reporting is a system that you need to have in place for your Quality Management System even if you are still MDD compliant.

If you get a serious incident or a Field Safety Corrective Action (FSCA) then below are the steps to follow.

In this episode of the podcast, we will talk about

• What to do when there is an incident?

Below you will have all the links.

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, podcasts, online courses…

• Q&A MIR form https://ec.europa.eu/docsroom/documents/41322/attachments/1/translations/en/renditions/native

The post How to implement Vigilance Reporting for MDR and IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi