Makers of Complete Branded Instrument Systems
Our mission is simple: Make the finest orthopedic instruments on the planet.
We've dedicated our business to developing branded instrument systems that look better, feel better and are easier for surgeons to use. So rather than a large sales team, we've always set ourselves apart with our smart, innovative team of engineers.
leave their mark on everything we make.
With the most talented team of engineers in the industry, our customers have come to rely on us to develop original ergonomic handle designs and breakthrough features. Whether we are improving an existing instrument or developing a unique custom product, our engineering team is here to work with you to achieve the most innovative designs possible.
Details. The difference between good and great.
When you work with Gauthier,
quality isn't just expected, it's a given.
From product concept through development, procurement, manufacturing and delivery, the utmost care will be taken to meet our customers' expectations and to comply with regulatory requirements.
Quality and Regulatory System
- Since 2000, FDA registered as a manufacturer and contract manufacturer, Registration #2134947
- Quality system is ISO 13485:2016 certified
- Provide regulatory consulting and ability to offer OEM product
- Design Files/Sterilization & Cleaning Validations/Packaging/Labeling/IFUs
- Design and Process FMEAs
- Gage R&R
- Verification & Validation parts – test process flows
- In-process and Final Inspections - CTQ
- Systemic improvements based on:
- Non-conformance trends
- Customer Complaints
- Process monitoring
- Supplier management
- Strong Root Cause Analysis for Effective Corrective & Preventive Actions