Contract Design and Manufacturing
Our principals offer a wide range of expertise to aid in device design and manufacture.
Device Design
- We can help with Market Specification to Product Specification through Engineering Specification and manufacturing
- We document all steps and processes to either aid in or handle the submission of information to the FDA
- We have experience with Class I, II and III devices as well as 510k's and PMA's
- We work with everyone from start-ups to the largest medical companies in the world
- We have capabilities from 1 piece prototypes through manufacturing
- We can work with virtually any materials from plastics to metals through biodegradable implants
- Nano molding capabilities
- Clean room assembly
- Packaging, labeling, and sterilization
- Pulmonary
- Urology
- Gastroenterology
- OBGYN
- Cardiology
- Nephrology
- Neurology
- Thoracic Surgery
- Laparoscopy
- Dental
- Balloon dipping and thermoforming
- Catheter technology including extrusion and assembly expertise
- Steerable
- Balloon
- Gas handling and fluid control
- Imaging Systems
- Instrumentation development
- Power systems
- Medical packaging and sterilization
- Automation systems