Medical Device Manufacturing
TRICOR Systems is an FDA registered, ISO 9001:2008 & ISO 13485:2003 certified design and medical manufacturing facility. Founded in 1976, TRICOR Systems has successfully provided high quality products and services to the medical market place.
TRICOR possess the expertise to design, develop, validate, and manufacture Class I, II and III electronic medical devices. Whether you are looking for a complete turn key solution, or just supplementing your internal capabilities, TRICOR has the background and flexibility to meet your requirements. TRICOR offers the opportunity to confidently outsource your project needs.
TRICOR utilizes the latest computer technology for all aspects of the organization from the Enterprise Resource Planning (ERP) software, to computer aided engineering tools listed below.
Examples of Contract Manufactured Medical Devices
- Dental Anesthesia Delivery Systems
- Thermo Therapy Systems
- Automated Disinfectors
- Medical Anesthesia Delivery Systems
- Electrical Teeth Whitening Systems
- Endoscope Leak Detection Systems
Medical Contract Manufacturing Capabilities
TRICOR Systems electronic contract manufacturing capability is structured to produce a wide variety of products for its customers. TRICOR can manufacture small quantities of prototypes and pre-production units to large quantities such as the 50,000+ unit/year rate achieved on the Wand Dental System. Our experience with both Class I, II and III medical 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 manufacturing and medical device design
- 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 system (ERP)
- Test: Qualification through burn-in
- Full service device packaging
- Drop shipping
- Repair depot
- Device history record generation
- Quality Assurance System:
- Certified to ISO 9001:2008 & ISO 13485:2003
- Compliant to cGMP
- Compliant to FDA Quality System Regulation (QSRs) 21 CFR 820
Medical Contract Engineering Capabilities
TRICOR Systems engineering provides outstanding capability not found in many small companies. From the design of simple fixtures to complete systems, the attention given to performance, reliability and quality does not vary.
Each engineer is proficient in both hardware and software design. This capability increases efficiency and reduces cost as the engineer who writes the operating software is intimate with the hardware he/she is trying to control.
Electrical Engineering tools/aids: The latest state of the art schematic capture and pcb layout tools form Mentor Graphics are used on all electrical design activities.
Mechanical Engineering tools/aids: To develop the highest quality mechanical items, TRICOR Systems utilizes both Autocad and the advanced 3-D solid modeling tools offered by Solidworks®.
As products become more sophisticated , medical device performance is highly dependent on reliable, verifiable and maintainable software. TRICOR has a history of providing embedded and PC based architectures for numerous product requirements. By utilizing current development tools, coupled to a controlled design structure, the customer is ensured product and regulatory specifications are satisfied.
In addition to having the latest design tools, TRICOR possess the staff and expertise to design and develop electronic systems that meet all domestic and international safety requirements (IEC 60601 or UL 2601 and CAN/CSA-C22.2 60601).
- Engineering system certified to ISO 9001:2008
- Safety Requirements to IEC 60601 or UL 2601 and CAN/CSA-C22.2 60601
- Software Verification and Validation
- Product Definition
- Product and Design Validation
- Risk Analysis
- Perform hardware/software tradeoffs in order to achieve desired goal at minimum cost.
- Execute the electrical and mechanical designs needed for hardware fabrication.
- Compose and debug all related software.
- Breadboard and test various design approaches.
- Layout, verify and tool required printed circuit boards.
- Provide complete manufacturing documentation package.
- Procure/Fabricate subassemblies and systems.
- Assemble, test and debug subassemblies and systems.
- Support Manual Publication, e.g., theory of operation and troubleshooting procedures.
- Conduct qualification testing