How to find your Predicate Device for your 510K Submission?
The choice of a Predicate Device is important and challenging at the same time. Your predicate device is already on the US market, so all you must do is select it and confirm that your device is the same as the predicate and Bingo, you can register your product in the US. But this is not as simple as that. Beat Keller from imt in Switzerland will share with us his experience working on US submissions and provide some hints on what you should or should not do.
Who is Beat Keller?
Beat is the Head of Regulatory Affairs and Quality Management at IMT, a Swiss Consultancy and Engineering Service provider for medical device manufacturers. He has worked for more than 10 years in the medical device industry first as a software engineer, then as a project leader before he took over the Regulatory and Quality department of IMT.
Beat is also active in different standards working group as Co-Convenor of the “conformity assessment” working group of the Swiss standards association and member of different working groups on Swiss, European and International level for medical device standards.
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.
- Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/
- imt website: https://www.imt.ch/
- US FDA predicate device guidance: https://www.fda.gov/media/171838/download
- MDCG Guidance on Equivalent Devices: https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf