Ewald Jöbstl is a regulatory consultant for medical devices. He is owner of the company QM Jöbstl. He founded his company in 2010 after more than 30 years of international experience in quality management, regulatory affairs and the development of medical devices and IVD’s.
His core competence is the development and implementation of quality management systems and the support how to bring medical devices to the USA and European market.
He is a certified auditor, quality & regulatory affairs manager, system manager quality and certified trainer.
In his presentation he will speak about the basic requirements how to bring medical devices to the US-American market.
In this short presentation you will get an overview of the important steps towards FDA marked approval.
- The US market for medical devices and the role of the FDA
• Essential steps of the FDA clearance/approval procedure
• Product classification
• 510 (k) Premarket Notification
• Quality Systems Regulations (21 CFR 820)
• FDA inspections