Live webinar on The 510(k) Submission Process By Compliance2go 2011

Topics

• Types of 510(k) submissions
• When to submit a 510(k) for a new or modified product
• What is contained in a 510(k) submission package
• The submission process
• How is the submission package assembled
• How to know whether clinical data is required
• How to interact with the FDA and the reviewer
• User fees and 510(k) submissions
• What do to if you make a change to your device

Who should Attend

• Regulatory management
• Executive Management
• R&D personnel involved in approving the design of medical devices
• Professionals involved with premarket notification to FDA
• Sales personnel involved in approving the marketing of medical devices