How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD)
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
- Artificial Intelligence
And you’ll see that there are here a lot of tips for you to follow.
Who is Dr. Abtin Rad?
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.
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, podcasts, online courses…
Links from the Video
- Dr. Abtin Rad LinkedIn Profile: https://www.linkedin.com/in/dr-ing-abtin-rad-0601b744/
- TÜV SÜD Website : https://www.tuvsud.com/en
- TÜV SÜD Cybersecurity testing: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-testing/physical-testing-of-medical-devices/medical-device-cybersecurity
- TÜV SÜD Medical Devices Job board: https://www.tuvsud.com/en/careers/global-job-opportunities#/medical-devices-healthcare
- TÜV SÜD Software Quality testing: https://www.tuvsud.com/en/services/testing/software-quality-testing
- MDCG 2019-11 Software Qualification and Classification: https://ec.europa.eu/health/sites/default/files/md_topics-interest/docs/md_mdcg_2019_11_guidance_en.pdf
- DRAFT EU Artificial Intelligence Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021PC0206
- ISO/TS 82304-2 :2021: https://www.iso.org/standard/78182.html
- MDCG 2019-16 Cybersecurity for Medical Devices: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_cybersecurity_en.pdf
- IEC/DIS 81001-5-1: https://www.iso.org/standard/76097.html
- IEC TR 60601-4-5 :2021: https://webstore.iec.ch/publication/64703
- Podcast Cybersecurity with Erik Vollebregt: https://podcast.easymedicaldevice.com/67/