KKB's advice covers all aspects of medical device research and approval, including:

• Licensing and related issues for:
  • Investigational Device Exemptions (IDEs)
  • 510(k) Premarket Notifications
  • Premarket Approval Applications (PMAs)
• Compliance with post-approval requirements for changes in products, labeling and manufacturing processes
• Interpretation and application of FDA Quality System requirements
• Establishment registration and product listing
• User fees
• FDA reporting requirements