Prototypes & Production
We operate our high-tech production facility 24 hours a day, 5 days a week to quickly deliver commercial grade prototypes. Extensive machining, molding and rapid prototyping capabilities enable high precision fabrication of the most complex products.
The manufacturing processes created during the development of the product can be rapidly deployed to produce finished medical devices. We focus on initial production runs as well as small to mid-sized orders. We can supply even larger quantity orders through our world-class production partners. MedicineLodge is an FDA registered facility and is ISO 9001:2000 and ISO 13485 compliant.
On Demand Manufacturing
For even faster delivery, we provide a unique service called On-Demand Manufacturing™. This service gives you the opportunity to reserve time in our facility to receive priority scheduling as well as collaborate with our experienced manufacturing staff to optimize your products for manufacturability. By signing up for OnDemand Manufacturing™, we become an extension of your product development team and production facility.
Manufacturing Capabilities
- Rapid Prototyping
- CNC Milling
- CNC Turning
- CNC Swiss Screw Machining
- CNC Wire EDM
- Heat Treat
- Welding – TIG and Micro-TIG
- Finishing
- Passivation
- Ultrasonic Cleaning
- Laser Etching
Quality Management System
- FDA Registered Facility
- FDA 21 CFR 820 Compliant
- ISO 9001:2000 Compliant
- ISO 13485:2004 Compliant
- Policy
MedicineLodge shall use its Quality System to pursue its Mission and achieve its Quality Objectives.
MedicineLodge shall maintain compliance with its Quality System, strive for continuous improvement of its Quality System, and
institute periodic review of its Quality Policy, Mission, and Quality Objectives to ensure sustainability.
Quality Control
- Comprehensive Mechanical Inspection
- Hardness Testing
- Surface Finish Testing
Regulatory
- Design History Files
- Design Dossier/Technical Files
- Device Master Records
- Devices History Records
- FDA 510(k) Clearance