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Regulatory Affairs

In an area as important as regulatory affairs, you need expertise to avoid costly mistakes and to reduce delays. We can provide:

Regulatory Assessment; Class determination
Product Labeling
Marketing/Technical Support information
Writing and support of all types of regulatory submissions
  • 513(g) - Class determination
  • 510(k) - Premarket Notification
  • DMF - Device Master Files
  • PMA - Pre-market Approval
  • Pre-IDE Breifing Packages
  • IDE - Investigational Device Exemptions (for clinical trial leading to PMA)
  • HDE - Humanitarian Device Exemption
  • BLA - Biologics Licensing Application
  • CMC Sections - Chemistry, Manufacturing, Controls sections for IDE and PMA
  • Technical Files, CE Marking - for European regulatory agencies