Medical Device Manufacturing

TRICOR Systems is an FDA registered, ISO 13485:2016 certified design and medical manufacturing facility. Founded in 1976, TRICOR Systems has successfully provided high quality products and services to the medical market place.

We possess the expertise to design, develop, validate, and manufacture Class I, II and III electronic medical devices. Whether you are looking for a complete turnkey solution, or just supplementing your internal capabilities, TRICOR has the background and flexibility to meet your requirements. We offer the opportunity to confidently outsource your project needs.

Examples of Contract Manufactured Devices

LifePort Liver Transport Systems

After years of manufacturing the LKT100P and LKT101P Kidney Transporter Devices TRICOR Systems was awarded the design and development of the LifePort Liver Transport (LLT) device. Like the LKT, the LLT utilizes a peristaltic pump to profuse the liver during transport to provide a more viable organ for transplant.

Instrument Guidance Systems

The CompuFlo unit is a computer-controlled anesthesia delivery system for epidurals. TRICOR was commissioned to design a prototype and to support doctors with the development of a safer epidural spinal injection. TRICOR also assisted in writing the technical portion of the FDA 510K submittal for this Class II device in which the submittal was approved the first time through.

TEE Ultrasound Probe Disinfection Systems

The TD-100 is a Class II device manufactured at TRICOR since 1996. The TD-100 is the first automated disinfector designed to provide high-level disinfection of transesophageal (TEE) ultrasound probes. This microprocessor-controlled device provides easy interaction by the healthcare professional in charge of reprocessing the used TEE ultrasound probe.

Leak Detection Systems

TRICOR was awarded manufacturing of the Class II device, Veriscan LT. This program had a very aggressive schedule and was completed within a four month time frame. This automated endoscope leak detection system detects leaks with 99% accuracy. It detects endoscope leaks by utilizing an air pump to pressurize an endoscope and then monitoring changes in pressure. The early detection of leaks drives down repair costs and lowers the risk of cross-contamination.

Dental Anesthesia Delivery Systems

TRICOR designed the electrical portion and developed the software for the medical award winning STA. TRICOR is currently manufacturing the STA, which is a single tooth computer-controlled local anesthesia delivery system that ensures virtually pain-free, and ultimately fear-free injections. TRICOR assisted in writing the technical portion of the FDA 510K submittal for this Class II device.

Endoscope Drying Systems

TRICOR Systems Inc. was approached with an idea of developing a device to dry the internal channels of endoscopes after they had been cleaned and disinfected. The idea was conceived after several deaths were blamed on improperly cleaned endoscopes. Within months, TRICOR had completed the proof of concept, prototypes and production units. These Class I Exempt devices push HEPA-filtered air though tubing and disposable fittings into the internal channels of an endoscope.

Anesthesia Delivery Systems

The Wand™ is a computer-controlled local anesthesia delivery system that ensures virtually pain-free and, ultimately, fear-free injections. Within a four month time frame TRICOR was delivering 1000 units per week. In the following years TRICOR was then chosen to perform the engineering, hardware redesign and manufacturing for the Wand Plus, Compu-Med and Compu-Dent.

Thermo Therapy Systems

TRICOR was commissioned to take over manufacturing and later reengineered the TMX 2000 to the TMX 3000. The TMX3000 was a Class III device for treating the prostate. The TMX 3000 went end of life when it was replaced by a different technology.

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.

HIGHLIGHTS:

  • 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 9001:2015, AS9100D & ISO 13485:2016
    • Compliant to cGMP
    • Compliant to FDA Quality System Regulation (QSRs) 21 CFR 820

Medical Contract Engineering Capabilities

Our team of Engineers provide 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 extremely knowledgeable 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 from Mentor Graphics are used on all electrical design activities.

Mechanical Engineering tools/aids: To develop the highest quality mechanical items, we utilize 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 with a controlled design structure, the customer is ensured product and regulatory specifications are satisfied.

In addition to having the latest design tools, we have 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).

HIGHLIGHTS:

  • Engineering system certified to ISO 9001:2015 & AS9100D
  • Safety Requirements to IEC 60601 or UL 2601 and CAN/CSA-C22.2 60601
  • Software Verification and Validation
  • FMEA
  • 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
  • Conduct qualification testing