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Certifications

"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 FDA registered, 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.

ISO 13485:2003 CERTIFIED
FDA REGISTERED
OEM-TRAINED TECHNICIANS
QUALITY – SERVICE – VALUE