Confidence Beyond Compliance

Regulatory Strategy

  • Device definition
  • Classification of device
  • Clinical evaluation plan
  • Regulatory pathway determination

Pre-submission Interactions (with Regulatory Agencies)

Support for:

  • Interactive Q&A
  • In-person meetings

Design Validation – Clinical Evaluations

  • Clinical study submissions (e.g. IDE)
  • Clinical study compliance support
  • CER development

Submission to Regulatory Agency (for product approval / clearance)

  • 510k, PMA
  • Technical documentation for CE mark
  • License applications

On-going RA maintenance activities

  • Technical files / CERs
  • Labeling reviews
  • Post-market surveillance reports
  • Site registrations
  • Product listings
  • Export certificates
  • Import clearances

Design change analysis

  • Assessment of impact on regulatory approval / clearance