Manage episode 292187830 series 2591977
In this episode of the Podcast, we will explain to you what is the Emergency Use Authorization (EUA) that can be started in the US. And to help us, I have invited Michelle Lott from Lean RAQA.
This process was used a lot recently for Coronavirus products but you will see with Michelle that this process was changed so many times that it can create some headache.
Who is Michelle Lott?
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries. She has a weakness for tequila and anything barbecued.
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 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 now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
- Michelle Lott Linkedin Profile: https://www.linkedin.com/in/michellelottraqa/
- Lean RAQA website: https://leanraqa.com/
- FDA EUA Guidance: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
The post FDA: Is the Emergency Use Authorization worth it? (EUA) appeared first on Medical Device made Easy Podcast.