Detecto Receives International ISO 13485 Certification

The EN designates a “harmonized standard”, which means that the quality system is presumed to be in conformity with the quality requirements of the European medical device directives. Detecto is already ISO 9001 certified, and compliant with the regulations of the US Food and Drug Administration (FDA).

“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 Larry Hicks, executive vice-president of Detecto. “We continually strive to design and develop innovative quality products to meet the growing needs of our customers around the world.”

“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 Mark Levels, quality assurance administrator at Detecto. “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.”

The ISO 13485 standard has been tailored to the medical industry's quality system expectations and regulatory requirements. While it can remain as a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference between the two is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained.

Another difference is that ISO 9001 requirements regarding customer satisfaction are absent from the ISO 13485 medical device standard. Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements.

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International Organization for Standardization