Medical Device Manufacturing & Engineering
TRICOR Systems Inc, is a Medical Design Excellence Award winner, FDA-registered, ISO 9001:2008 and ISO 13485:2003 medical manufacturer and design facility.
TRICOR possesses the expertise to design, develop, validate, and manufacture Class I, II, and III electronic medical devices under one roof. Whether you are looking for a complete turnkey solution, or just supplementing your internal capabilities, TRICOR has the background and flexibility to meet your needs. TRICOR offers the opportunity to confidently outsource your project needs.
Contract Manufacturing Capabilities
TRICOR’s Contract Manufacturing capability is structured to produce a wide variety of products for its customers. TRICOR can manufacture small quantities of prototype and production units to large quantities such as the 50,000+ unit/year rate achieved on the Wand System. Our experience with both Class I, II, and III devices minimizes problems and facilitates quicker product turns. Changes or product updates are also streamlined due to TRICOR’s in-house engineering staff.
- Class I, II, and III Medical Device Manufacturer
- Electronic and Electro-Mechanical Contract Manufacturer
- Assembly and precision hand or machine soldering of printed wiring boards
- Thru Hole or SMT assembly
- Complete panel and chassis wiring
- Cable harness fabrication
- Mechanical assembly
- Computer-based manufacturing control systems (ERP)
- Test: Qualification through Burn-in
- Full service device packaging
- Drop shipping
- Repair depot
- Device History Record Generation
- ITAR Registered
- QUALITY MANAGEMENT SYSTEM (QMS)
- Certified to ISO 9001:2008 and ISO 13485:2003 and AS9100C
- Compliant to GMP
- Compliant to FDA Quality System Regulation (QSRs)
- 21 CFR 820
Contract Engineering Capabilities
TRICOR’s engineering provides outstanding capabilities not found in many companies. From the design of simple fixtures to complete systems, the attention given to performance, reliability and quality does not vary. TRICOR’s experienced engineers are in both hardware and software design.
Electrical/Mechanical/Industrial Engineering tools/aids: The latest state-of-the-art schematic capture and PCB layout tools from Mentor Graphics are used on all electrical design activities. To develop the highest quality mechanical items, TRICOR utilizes both 2D and the advanced 3D solid modeling tools offered by Solidworks.
As products become more sophisticated, medical device performance is highly dependent on reliable, verifiable, and maintainable software. By utilizing current development tools coupled with a controlled design structure, the customer is ensured product and regulatory specifications are satisfied.
- Engineering and Manufacturing system certified to ISO 9001:2008, ISO 13485:2003 and ISO AS9100C
- Safety Requirements to IEC 60601 3rd edition or UL 2601 and CAN/CSA - C22.2 60601
- PMA & 510k submission assistance
- Software Verification and Validation
- Product and Design Validation
- Risk Analysis
- Perform hardware/software trade-offs in order to achieve desired goal at minimum cost
Execute the electrical and mechanical designs needed for hardware fabrication
- Compose and debug all embedded and PC software
- Breadboard and test various design approaches
- Layout, verify and tool required printed circuit boards
- Provide complete manufacturing documentation package
- Procure/Fabricate/Test and Debug subassemblies and systems
- Support Manual Publication, e.g., theory of operation and troubleshooting procedures