The United States’ Largest Medical Scale Manufacturer Meets Additional Worldwide Harmonized Standard of Quality and Conformity
Webb City, MO – DETECTO, an industry leader in USA-made clinical weighing, has achieved EN ISO 13485:2012 certification for its design and manufacture of medical scales used in personal and professional settings.
ISO 13485:2012 is the most recent iteration of the ISO 13485 quality standard for manufacturers of medical devices. This international standard applies to the design, development, production, installation and servicing of medical devices and related services. The standard is published by the International Organization for Standardization (ISO). The EN designates a “harmonized standard”, which means that the quality system that satisfies the requirements of the EN ISO 13485:2012 standard is presumed to be in conformity with the quality requirements of the European Medical Device Directives. Additionally, DETECTO is already registered ISO 9001:2008 certified and compliant with the regulations of the Food & Drug Administration.
“DETECTO’s certification confirms that the design and manufacture of medical devices under our current quality management system complies with the requirements of the latest version of EN ISO 13485:2012. By working with our customers and employee teams, we are continuously improving manufacturability, functionality and reliability of our complete line of medical weighing devices while meeting all regulatory requirements,” said DETECTO Executive Vice-President Larry Hicks. “We continually strive to design and develop innovative quality products to meet the growing needs of our customers around the world.”
As the United States’ largest medical scale manufacturer, DETECTO remains focused on improving the processes that go into the production of all of the company’s clinical scales and related products. The ISO 13485 standard highlights that improvement in the development, operation, and management of its medical devices. This standard helps to create awareness globally that the company creates a medical device and aids in improving that device at all levels, from conception to manufacture, by providing a systematic approach of improving the efficiency and productivity of that process.
“This is the culmination of a two-year project to obtain EN ISO 13485 certification in which hard work and dedication from all of DETECTO’s employees came together,” said DETECTO Quality Assurance Administrator Mark Levels. “To our customers, this demonstrates a dedication in complying with worldwide standards for manufacturing medical devices and our commitment to continually improving and growing. This will open up our products to additional international markets and translate into new growth for DETECTO.”