Regulatory & Clinical Support

AuST provides strategic regulatory, clinical, and quality support throughout the product development process.

Regulatory services include:
  • Global regulatory strategy development
  • FDA meeting preparation and attendance
  • Preparation of regulatory submissions for medical devices, including Pre-Submissions, IDEs, 510(k)s, PMAs, de novo applications, HDEs, 513(g) and Request for Designation
  • OUS regulatory filings, including technical files and design dossier compilation and Health Canada License applications
  • Labeling and marketing material review
Clinical services include:
  • Clinical Strategy Development
  • Clinical Protocol Development
  • Investigator Brochure Development
  • Clinical Procedure On-Site Support
Quality services include:
  • Quality System development and implementation
  • Training on regulatory and quality processes
  • FDA inspection preparation (QSIT & BIMO)
  • Post-market support