Identify your device classification according to MDR and US FDA regulation
With regulatory and quality assurance specialist Merete Hansen
“Identify your device classification according to MDR and US FDA regulation”
With regulatory and quality assurance specialist, Merete Hansen
What is this class about?
We present the MDR rules for the different risk classification and run through the FDA databases to find the regulatory pathway and potential predicate devices This class will be hosted on Team and the link will be emailed to you after your registration and payment.
Why should I attend?
Merete Hansen will walk you through the regulation in the key market area for medical devices; EU and US including the newest regulation. Merete will show you where to find the separate rules. How to determine the classification in EU? Map out the separate pathways in US and understand the concept of predicate and how that can guide your potential indication for use.