ISO 13485 certifies that the management system, manufacturing processes, and documentation procedure have all requirements for standardization and quality assurance 

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I was put in charge of certifying all new equipment, machinery, and fixtures around the company by creating equipment inspection forms and placing them into the lot history file. Performed Installation / Operation / Performance Qualification for machinery such as ultrasonic welders, Haas CNC Mills, soldering iron, ultrasonic baths and other equipment that was used in the production of the THERMIva, a device that uses radio frequency energy to heat and heal tissue, particularly in the vaginal wall post birth. 

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