Mount Mfg ISO 13485:2016

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Mount Mfg Announces ISO 13485:2016 Certification for Quality Management System!

Mount Mfg was recently presented with its ISO 13485:2016 certificate from Intertek, affirming that the company’s Boyne City, MI operation adheres to the internationally-recognized standard for Medical Device Quality Management Systems.

Mount Mfg is a privately held ISO 13485:2016 certified contract manufacturer providing manufacturing services for medical device companies. Mount Mfg is headquartered in Boyne City, MI. Mount Mfg provides development and manufacturing services for domestic and international medical device companies.

Seeking ISO 13485 certification was an immediate goal for Mount Mfg. The certification ensures a working quality system is in place and meets the rigorous requirements of ISO 13485:2016. The company started raising capital to purchase medical manufacturing equipment in December of 2016. We now have a full manufacturing facility, staffed with manufacturing and quality engineers, and a quality system that is intended to advance the company’s processes while maintaining and evidencing compliance to the appropriate regulatory authorities and customer requirements. – Eric Lintula, Mount Mfg’s CEO.