ISO 13485 CERTIFIED
Minnetronix Guide |
Home | Quality Quality We are dedicated to helping our customers succeed. Minnetronix is committed to delivering high-quality medical products and services. We believe that a quality system should be a tool for superior systems design and manufacturing, not a barrier. Our quality system reflects this philosophy. Minnetronix has developed a set of sophisticated, proprietary quality system tools that enable us to automate and document the design and manufacturing process. Auditors have described our system as a "benchmark in electronic record keeping." Minnetronix Quality System Structure Our quality system consists of our quality management system manual, standard operating procedures (SOPs), procedures, and records. We regularly update our procedures to ensure that we continuously improve our device commercialization process, and to maintain our regulatory compliance. Minnetronix has established and applies a quality system for: contract design, development, manufacturing, commercialization, and repair of medical electronic products. Minnetronix is FDA registered, ISO 9001 and ISO 13485 certified, and has undergone three successful FDA QSIT inspections with no findings or observations (2001, 2004, and 2008). View our ISO certificate here (registration No: S 951 06 3991).
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