Quality

Setting the Industry Standard

We put the care, attention, and precision into every medical product we make as though it will be used to care for our loved one – because we know it could some day. That’s why we hold ourselves to a higher quality standard that is embedded into our organization, culture, and systems. We implement strict protocols, processes, and rigorous testing to reduce errors and improve efficiencies, all of which have been honed through years of meeting the quality requirements of leading global medical companies.

Tools & Resources

Regular audits by independent certification bodies

Comprehensive inspection systems, including machine vision system and coordinate measuring machine (CMM)

Internal and external regulatory affairs expertise available to assist with filings,protocol development, and other regulatory issues

Six sigma black and green belts

Minitab data analysis, Statistical and Process improvement software

Process

ISO 13485:2016 MDSAP

ISO 9001:2015 Certificate

Adherence to QSR -GMP standards (audited by third party standards body)

Validated and certified ISO 14644-1 Class 7 and 8 cleanrooms with an environmental bioburden monitoring system and full IQ/OQ/PQ documentation

ASQC Certified Quality Engineers


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