How to perform a Biological Evaluation for your Medical Device?
We talked a lot about the regulatory requirements for your Medical Devices. Now let’s talk about something more technical which is the Biological Evaluation following ISO 10993-1 or also called Biocompatibility.
This is something that is key for the Medical Device Manufacturers but it is also not well understood. So Ana Luiza Cassin Duz, a Clinical Specialist for Medical Devices is helping us. She will answer all my questions on Biological Evaluation and I am sure there is something that will surprise you.
Don’t hesitate to ask your questions in the comments.
Who is Ana Luiza Cassin Duz?
She holds a Bachelor’s Degree in Biological Sciences, a Master’s Degree in Cellular Biology, a Ph.D. in Biological Sciences, and an MBA in Quality Management.
She has worked for the past 10 years in the quality, regulatory and clinical evaluation of various types of medical devices, such as Biological Heart Valve, Endoprosthesis, Inorganic valved conduit, Annular Rings; as well as, Extracorporeal circulation machine, Defibrillator, Cardioverter, and Patient monitors; in addition to Intrastromal corneal ring, Intraocular lens, and Contact lenses.
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 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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…
Links
- Ana Luiza Cassin Duz Linkedin Profile: https://www.linkedin.com/in/ana-luiza-cassin-duz-clinical/
- ISO 10993-1 standard: https://www.evs.ee/en/evs-en-iso-10993-1-2020
- TUV SUD Biological Evaluation: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/iso-10993-biological-evaluation-of-medical-devices
