Minnetronix, maintaining our perfect record, has now undergone seven successful FDA Quality System Inspection Technique (QSIT) inspections with No Action Indicated (2017, 2016, 2015, 2010, 2008, 2004 and 2001). We achieved this milestone by continually assessing and improving our Quality Management System (QMS). In a typical year, our system is subjected to more than 30 audits by regulators and customers in addition to our own internal audits. We use the audits as a tool to help identify weaknesses and improvement opportunities, which further enhances and strengthens our processes and systems.
Our state-of-the-industry QMS encompasses design, development, manufacturing, commercialization, and service of medical electronic and electromechanical products. The Minnetronix QMS is a true Original Equipment Manufacturer (OEM) medical device QMS and meets all of the requirements of the medical device regulations. Our QMS is based on continually improving our development, manufacturing, and business processes. Our structured and agile quality system allows us to tailor our services to meet individual program needs and to achieve the best outcomes for your business.
Our continued perfect record with FDA inspections underscores Minnetronix’ commitment to quality as we create new technologies and therapies that solve unmet clinical and business needs for patients and medical device companies.
Vice President of Quality and Regulatory Affairs