FDA: Advantage of the Breakthrough Device Program
In this episode, Michelle Lott will walk us through the Breakthrough Device Program created by the FDA. Who can benefit from it? And what are the benefits? The post FDA: Advantage of the Breakthrough Device Program appeared first on Medical Device made Easy Podcast. hamza benafqir
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Show Notes
In this episode, Michelle Lott will walk us through the Breakthrough Device Program created by the FDA. Who can benefit from it? And what are the benefits? Michelle will explain if you can be part of this and how to do it also. So stay tuned.
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 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.
Link
- Michelle Lott LinkedIn: https://www.linkedin.com/in/michellelottraqa/
- Company page : https://leanraqa.com/
- FDA breakthrough devices program guidances: https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
Social Media to follow
- Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
- Twitter: https://twitter.com/elazzouzim
- Pinterest: https://www.pinterest.com/easymedicaldevice
- Instagram: https://www.instagram.com/easymedicaldevice
The post FDA: Advantage of the Breakthrough Device Program appeared first on Medical Device made Easy Podcast. hamza benafqir