The 21 Elements of a 510(k) is a webinar that covers topics such as:
The 21 Required Elements in the 510(k), and How Documented
The Three Types of 510(k)s and Their Uses
Addressing Product "With-" or "As-software" Issues
Finding, Proving and Documenting Substantial Equivalence
Documenting "Hazards Analysis", and the MAUDE Database
The "Statement" or The "Summary"
U.S. FDA Device Clearance Process
The Declarations
The 21 Elements of a 510(k) brings together:
Coordinators
Investigators
Health SSenior management
Contract/Budget Negotiators
Quality Assurance
Regulatory Affairs
R&D and Engineering
Production
Clinical Research Billing Compliance Staff/ Officers
All personnel involved in a U.S. FDA-regulated environment especially those involved in new product development, line extensions, and incremental product improvements, having to evaluate those changes to existing FDA-cleared 510(K)`s, and then document their decisions in harmony with regulations.ystem Administrators
Past Events
The 21 Elements of a 510(k) - Webinar By ComplianceOnline 2012 - 05 Jun 2012, Webinar (30531)
Important
Please, check "The 21 Elements of a 510(k) - Webinar By ComplianceOnline" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Medical device, Medical laboratories, Pharma