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Our Quality Management System is built around ISO 13485 requirements with a focus on processes developed to meet our Quality Policy commitments. Utilizing the Master Device Record (MDR) methodology to manage the controls and lot information from each manufacturing lot.

  • IQ/OQ/PQ validation methodology

  • On-line Process and quality data collected and evaluated in computer database

  • Components are manufactured in a clean Class ISO 8 environment

  • Hands-off component collection and packing processes

  • Manufacturing Control System (MCS) and database places necessary process information and documentation at points of use

  • Component is labelling created from MCS real time to minimize labeling mistakes

Medical Components of America is an ISO 13485: 2016 certified company, registered by BSI, Number: FM651851

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