Welcome to Tenacore
Tenacore provides many different solutions under one roof including but not limited to the following:
Tenacore is constantly servicing hospitals across all 50 states and providing many hospitals with a total solutions of all medical equipment repairs.
Medical Device Manufacturing
Tenacore proudly manufactures OEM spec products to thousands of hospitals including but not limited to wall suction regulators, oxygen blenders, fetal transducers, and many other parts for your OEM products.
Tenacore specializes in custom molding services such as DNA collectors, injection molding, CNC, swiss screws, printing, and much more.
Tenacore recently expanded to the United Kingdom to also provide products and services overseas, and will continue to expand to many other countries in the near future.
Medical Electronics is a subsidiary of Tenacore which provides biomed contracts, compliance, preventive maintenance support, anesthesia support, and much more.
Mesh Candy offers a foundation for intelligent, real-time asset locating, messaging, environmental data collection and advanced analytics. The platform meets the needs of frontline workers (like health care professionals) who, on a day-to-day basis, need to keep track of equipment, comply with environmental monitoring regulations and communicate with team members.
Tenacore is committed to ensuring the quality of our innovative medical products, accessories, and services by meeting our customer needs while complying with required regulations and standards and maintaining the effectiveness of the quality management system.Tenacore Holdings, Inc is a ISO 13485:2003 certified manufacturer and repair depot. This implies compliance with all relevant regulations per the US Food and Drug Administration and all international quality standards pertaining to the design and manufacturing of medical devices.
What is ISO 13485:2003?
ISO is the International Organization for Standardization and is the world’s largest developer and publisher of international standards. They provide solutions that meet the requirements of business and the broader needs of society. ISO 13485:2003 provides requirements for quality management systems which aid in the design, development, manufacturing, installation, and servicing of medical devices.
Tenacore ensures a superior quality system over other service and manufacturing depots by:
- Conducting 100 % quality control inspection on all finished devices and repairs
- Complying with ISO 13485:2003
- Periodically calibrating all equipment used for testing, measurements and calibration to the NIST Standards
- Complying with most international standards and other industry standards for quality inspection procedures.
- Having complete traceability for all devices that are manufactured or serviced.
Tenacore Holdings was started in Laguna Hills, CA, in 2000 by Peter Bonin and Brand Caso as a medical products distribution company, primarily in suction regulators, flowmeters, and monitoring accessories.
They quickly outgrew their space, and needed room to grow. They contacted Newport Plastics in Santa Ana, and leased a small corner office from them.
As Tenacore grew, they continued to lease more office space from Newport Plastics, eventually reversing the two company’s roles, such that Tenacore had all of the office space except for one office, which housed Newport Plastics.
As Tenacore’s distribution business continued to grow, they saw a need for equipment repair. In 2002, a small repair center was built in a corner of the warehouse, and suction regulators, fetal monitors, and transducers were repaired. This service quickly expanded into EKG cable, monitor module, and blender repairs, resulting in the construction of two additional repair centers. Tenacore now has multiple repair centers in our building, repairing suction regulators, O2 blenders, flowmeters, fetal monitors, Toco ultrasounds, monitor leads, monitor modules, physiological monitors, infusion and syringe pumps, telemetry modules, and both rigid and flexible endoscopes.
The expansion into the repair business opened another window of opportunity for Tenacore. There existed a need for a source of high quality components for device repair, reliable delivery of the components, and reasonable pricing. Tenacore purchased Newport Plastics in April of 2008, and started making their own repair kits for many of the products they were fixing. The increased quality, shorter lead times, and lower cost to the end users spurred even more growth. This then led to the manufacture of complete products, starting with fetal monitors and Toco ultrasounds, followed by EKG leads, SPO2 probes, blenders, and suction regulators.
Tenacore now has 9 injection molding machines, 5 multi-axis, multi-tool screw machines, our own mold making shop, and 3 ISO Class 7 clean rooms. Tenacore recently moved into a 40,000 square foot facility, which allows us more room for growth, and better process controls to continue to serve our customers.
Tenacore has achieved a number of certifications, including ISO 13485:2003 and CE. We are certified by the FDA and by the State of California Food and Drug Branch as a medical device manufacturer, and hold our own 510(k) approvals for the relevant products.
We will continue to expand our device repair capabilities, and use the knowledge obtained through these repairs to design new, improved products that overcome the most common repair issues.