OUR WORK

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.

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Contract

Manufacturing

We are a turnkey contract manufacturer.


We build to order, warehouse and ship direct to final customer.

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