Our services

Regulatory Affairs Consulting

510 (K) Pre-Market Notification

  • Identify and review type (Traditional, Abbreviated or Specialized) and class of application
  • FDA Form 3514 Review
  • 510k Summary or Statement Review
  • Device Description Review
  • Proposed Labeling Review
  • Sterilization, Shelf Life, Biocompatibility Data Review
  • Software Disclosure Review
  • Electrical Safety and EMC disclosure
  • Accurate Performance Data General
  • Ensure accurate entry of Performance Characteristics

Our brands and projects