Topics
- Definitions of key terms
- Review of applicable statute(s) and regulations to 510(k)s
- Discuss recent changes in the 510(k) program?
- Discuss substantial equivalence
- Discuss how to identify regulatory requirements relevant and applicable to the product(s)
- Discuss the differences between 510(k)s for other devices and those for in vitro diagnostic devices
- Discuss applicable, relevant voluntary standards useful for meeting the requirements
- Discuss regulatory requirements for premarket notification [510(k)] submission for in vitro diagnostic devices (IVDs)
- Discuss how to increase 510(k) submission quality for a product
- Discuss how to prepare a 510(k) for IVDs in a systematic, integrative manner
- Discuss speaker’s practical and actionable strategy "CAC-SI" method
Who should Attend
R&D Scientists, Engineers, Managers, Directors, and VPs, Regulatory Affairs Managers, Directors and VPs, Compliance Officers and Legal Counsel, Quality Engineers, Managers,Directors, and VPs, Business Development Managers, Directors, and VPs, Marketing Managers, Directors and VPs, Site Managers, and Directors, Complaint Handling and Risk Management Managers and Directors, Senior and Executive Management and Consultants.
