The 21 Elements of a 510(k) - Webinar By ComplianceOnline 2012

Topics

• 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

Who should Attend

• 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