BMP Medical’s Quality Management System is certified to ISO 13485:2016. Our Quality Management System is fully compliant with FDA 21CFR820 and cGMP. BMP Medical has devices registered with the FDA (Ref. Registration # 1220502):
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Statistical Process Control and Development
BMP Medical utilizes Statistical Process Control on its most critical components where precision matters most. While practicing the scientific molding process development as the first step, our engineers can dial in a tight process window to control how the parts are produced, as well as procedures to monitor that process. BMP Medical also uses ancillary monitoring equipment to monitor the processes in the tool, as well as when the parts are pulled out of the mold. We also use statistical analysis software during validation to analyze the data generated by the Quality Control team to verify parts are being made to specification and that the process is controlled.