Our Work
Innovative, Reliable & Robust Design
7D SURGICAL
Spinal & Cranial Surgical Navigation System
- Electrical Wiring Design
- Mechanical Head Design including DFM
- Industrial Design of Head
- Managing 3rd Party Cart Design House
- Prototyping of 510k device
- EMC & Electrical Safety Testing Management
- Full-Scale Manufacturing
- Part Obsolescence & Supply Management
- Reliance Program: Reach, RoHS, Prop 65, & Conflict Mineral Management
INNOVERE MEDICAL
In-bore MRI Entertainment System
- Reliability Engineering
- HALT Testing
- Natural Frequency Testing
- Design for Manufacture
- New Product Introduction
- Work Instruction & DHR Creation
- Prototype Production
- Full-Scale Manufacturing
THORNHILL MEDICAL
Portable Intensive Care Unit
- COVID-19 Response Engineering Support
- Test Fixture Design, Creation & Documentation
- DMR Management & Transfer to Contract Manufacturer
- Engineering Change Management Support
- Quality Engineering Support
- PCBA Design and Layout
- Reliance Program: Reach, RoHS, & Prop 65 Management
MEDISTAR - IVPair
COVID-19 Air Filtration System
- Electrical System Design
- Component Selection & Bill of Materials Generation
- High Current PCBA Design
- Software Development of Control System and GUI
- Preliminary Safety Compliance Assessment
- Prototyping & PCBA Production
STEROZONE (formerly MEDIZONE)
Room Disinfection Device
- Modified Mechanical Design for Useability and Manufacturability
- Redesigned PCBA and Cable Harnesses
- Ensured Mechanical and Electrical Design met IEC 61010 Standard
- Managed DMR & Design Changes over 7-year period
- Created software change documentation for ISO 62304 compliance
- Managed Ozone Generator Replacement Design
- Supported prototype builds with new components and assembly
CONAVI MEDICAL
Rotary Coronary Ultrasound & OCT Imaging Catheter Device
- Electrical System Design (Cables, PCBAs)
- Complex Mechanical Design of Locking Mechanisms, Clamping Jaws, Rotating Spindle and Linear Gantry
- Injection molded plastic design of Catheter Interface
- Industrial Design
- Vibration Analysis
BRAINSVIEW
Brainwave Analysis & Visualization Software
- Developed data formatting and analysis software to calculate brain index according to algorithm
- Developed GUI including presentation of brain waves and index on computer
- Developed configuration file to allow for modification of parameters for research purposes
- Subsequently updated program to allow for reading of alternate data-source file type
TRUDELL MEDICAL
Electronic Inhaler Monitor for Clinical Trial Compliance
- Rapidly Redesigned PCBA to meet ESD and EMC requirements
- Lightning-fast prototype PCBA production (8 calendar days)
- Developed EMC test protocol for use by the 3rd-party test house
- Managed the test interactions with the 3rd-party test house
- Handled poor leakage test results by declaring acceptance to an alternate, more applicable standard
- Fixed firmware to enable device functionality
- Updated Risk Analysis for all EMC issues
Explore our services
Product
Development
We provide full-scope product development.
We do everything from product strategy, to concepts, to detailed design, to protoyping & to manufacturing transfer.
Contract
Manufacturing
We are a turnkey contract manufacturer.
We build to order, warehouse and ship direct to final customer.
