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 Strategy Development
- Clinical Protocol Development
- Investigator Brochure Development
- Clinical Procedure On-Site Support
- Quality System development and implementation
- Training on regulatory and quality processes
- FDA inspection preparation (QSIT & BIMO)
- Post-market support