Successful 510(k) submission: Contents and Format 2012

Topics

• How to identify a predicate device(s), if any
• Applicable Statute(s) and regulations for 510(k)s
• Recent changes in the 510(k) program
• How to demonstrate substantial equivalence
• Differences in contents of 510(k)s based on products
• Decision points during 510(k) review
• How to address the relevant and applicable regulatory requirements
• How to identify regulatory requirements relevant and applicable to the product(s)
• How to increase 510(k) submission quality for a product
• How to present your performance data and clinical data in a succinct, comprehensive manner

Who should Attend

• Clinical Affairs Managers, Directors and VPs
• Regulatory Affairs Managers, Directors and VPs
• Quality Managers, Directors and VPs
• Quality Managers, Directors and VPs
• Sales and Marketing Managers, Directors, and VPs
• Compliance Managers and Directors
• Site Managers, Directors, and Consultants
• Complaint Handling and Risk Management Managers and Directors
• Compliance Officers and Legal Counsel
• Senior and Executive Management
• Business Development Managers, Directors, and VPs