2020 - Successful 510(k) Submissions

Basic U.S. FDA's expectations and requirements for the 510(k) submission
The Three Types of 510(k)s and Their Uses
The 21 Required Elements in the 510(k), and How Documented
Finding, Proving and Documenting (formats for) Substantial Equivalence
Addressing Product "With-" or "As-software" Issues
The "Statement" or The "Summary" – which?
Documenting "Hazards Analysis", the MAUDE Database, Human Factors
The Declarations
U.S. FDA Device Clearance Process