Biological Evaluation: Top Big mistakes
In this podcast episode, Laura and Paul will share with us the big mistakes done by some Medical Device manufacturers when they are considering Biological Evaluation for their products.
You may need to take some notes as Laura and Paul are really knowledgeable on this process as they are onboarding some of their customers at ICARE Group and they will share with us the good, Bad, and ugly.
Don’t forget also to check their webpage to see what Icare can provide to you as a service.
Who is Paul Fernandez?
Holder of a Master’s degree in Toxicology and after a brief training in nutrition research, he began his career in regulatory affairs specializing in medical devices at ICARE when the MDR came into force. Curious by nature, and specialized in biocompatibility testing and in biological/toxicological risk analysis, he accompanies and guides many MD manufacturers in their biological evaluation strategy and after audit with authorities. He is currently a referent for the biological and toxicological safety of MD within Groupe ICARE.
Who is Laura Fouzari?
Following a master degree in toxicokinetics and toxicology, LF has specialized in the medical device sector and has started working on these themes for 4 years. Nowadays, she is working as a safety and toxicological safety assessor in the Regulatory Affairs Unit within the Biotox Unit of Groupe Icare.
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, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
- Icare Group: https://www.groupeicare.com/
- LinkedIn Paul Fernandez: https://www.linkedin.com/in/fernandesp
- LinkedIn Laura Fouzari: https://www.linkedin.com/in/laura-f-712865150/
- FDA document: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and
- Webicare subscription: https://www.groupeicare.com/events/webicare-etude-alternative-focus-chimie/