AuST provides strategic regulatory and quality system support to guide clients through the regulatory process.
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
• Labeling and marketing material review
• Quality System documentation development
• Training on regulatory and quality processes
• FDA inspection preparation (QSIT & BIMO)
• Post-market support