How to perform Risk Management for a Software ?
In this episode, Bijan Elahi will help us perform risk management for SaMD and give us some tips on the best strategies. Bijan is also the author of the book “Safety Risk Management for Medical Devices”.
If you have to perform risk management for a software as a Medical Device or Medical Device software you may think how this can be done?, Are the tools, standards, the same as for normal medical devices? Are the risks different? Bijan Elahi will be my guest on this episode and will explain to us the best practices for SaMD risk management. Don’t miss this and also his book called “Safety Risk Management for Medical Devices”. Link below.
Who is Bijan Elahi?
Bijan Elahi has worked in safety risk management for medical devices for over 25 years at the largest medical device companies in the world, as well as small startups. He started his work in risk management in aerospace; last working on the Space Shuttle at NASA before transitioning to the medical device industry in the early 1990’s.
Bijan is the corporate expert on risk management at Medtronic. In this capacity, he offers education and consulting on risk management to all Medtronic business units worldwide. Bijan is also a lecturer at Delft University of Technology, and Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the book Safety Risk Management for Medical Devices.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, youtube videos, linkedin Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
- – Bijan Elahi LinkedIn Profile: https://www.linkedin.com/in/bijanelahi/
- – Book: “Safety Risk Management for Medical Devices”: https://books.google.fr/books/about/Safety_Risk_Management_for_Medical_Devic.html?id=UzU4EAAAQBAJ&redir_esc=y
- – Episode 207: Why Risk Management is important to Medical Device development: https://www.youtube.com/watch?v=cFmVpYkQ0wk
- – Episode 216: How to evaluate Benefit-Risk ratio for Medical Devices?: https://www.youtube.com/watch?v=7fimKKqBtEY
- – Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/