How to certify your Software as a Medical Device? (SaMD)
Do you have a Software as a Medical Device or maybe you plan to have one? Then listen to this episode with Vivek Thakkar which will provide you some insight on what is SaMD and how to get Certified. If you need more details, please contact us so we can help you.
Who is Vivek Thakkar?
Regulatory affairs professional with a Master’s degree and 12 years of experience with Class II and Class III medical devices. Currently supporting regulatory activities for Artificial Intelligence and Machine Learning (AI/ML) in Software as a Medical Device (SaMD). Proven success in building and executing global regulatory strategies for interventional cardiovascular products. Skilled at hiring, training, and inspiring regulatory experts for medical device submissions. Passion for simplifying
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing 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…
- Vivek Thakkar Linkedin: https://www.linkedin.com/in/vivekbthakkar/
- Blog post SaMD: https://easymedicaldevice.com/SaMD
- Clinical Evaluation Software: https://www.youtube.com/watch?v=HIycmCuBsi0
- Podcast Cybersecurity: https://podcast.easymedicaldevice.com/67/