Regulatory Submission Highlights

1. SARA L. THEIS
Regulatory Experience Overview
• 510(k) Authored the following sections in Two 510(k)s:
o Device Description
o Labeling
o Sterilization and Shelf Life
o Biocompatibility
o Performance Testing (Bench Studies, Animal Studies and
Clinical Studies)
o Performance Characteristics
• PMA Class 3 Tumor Marker Assays (Breast Cancer and
Gastrointestinal Cancer) product registrations to multiple International
Markets
o Wrote dossiers for International Markets with PMA content
• International Markets Submissions: 100+ submissions in predominantly
Class 2 and 3 In-Vitro Diagnostic Devices
• Team contributor on Pre-IDE on a Class 3 Campylobacter Rapid Test
Device
o Defined Outside US markets of Australia and Canada for limited
launch
• Participant on the Quality Management Review Board (MRB)
• Device experience with Instruments and Laser Systems:
o Several electrified instrument analyzers (IVD)
o 5 Laser Surgical Systems
o Dental Medical Devices
 Multiple Class 2 hand instruments and drills (U.S.)

2.  1 Dental Surgical Tray (Canada - Class 3)
 Several Dental Accessories (Class 1)