TriE's Services

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TriE's product development team works with clients to take "medical device ideas" from the initial concept phase through full product development, while maintaining the necessary FDA standards, certified testing, validation requirements and documentation. TriE's core areas of product development and medical product design expertise include:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Design Assistance
  • Medical Devices Designed for FDA: Class I, II, and III
  • New Product Development
  • Prototyping
  • Therapeutic Device Development
  • Gas Delivery System Development
  • Catheter Development
  • Biomedical Monitoring Device Development
  • Drug Delivery System Development
  • Pharmaceutical Device Development
  • Combination Product Development
  • Clinical Feasibility Studies

 

Software Development

  • Full Software Development
  • Embedded Systems
  • Wireless Systems
  • High Level Assembly Languages
  • GUI User Interfaces
  • Motion Control
  • Real Time Systems
  • Embedded Linux Systems
  • Embedded Windows Systems
  • LABVIEW Programming
  • Multi-tasking control
  • Microprocessor Programming
  • Software Verification and Validation

 

Documentation Assistance

  • Technical Dossier needed to obtain FDA 510K, PMA or IND submission package.
  • System Requirement Documents
  • System Specifications Documents
  • Study Report Generation
  • Test Protocols and Test Reports
  • FMEA (Failure Mode Effects Analysis)
  • System Verification and Validation Documents
  • Quality and Regulatory Controls
  • Device History Files
  • Documentation Control

Product Testing Assistance

  • Certified Testing to Meet ISO, CE, FDA, UL Requirements

Animal Studies and Clinical Trials

  • Assistance in setting up Animal Studies
  • Clinical Trials Support

 
  • System Training
  • Service Center for Device During Clinical Trials (ie. System calibrations and maintenance).

Manufacturing Assistance

  • Integration into Customer's Manufacturing
  • Process Validation
  • Custom Designed Manufacturing Test Fixtures

 

TriE can be of service to your organization in achieving  objectives, meeting the necessary industry standards, developing a new product or redesigning an existing product.  We look forward to assisting your organization, in business ventures with our medical device expertise and outsourcing options.