Tuesday 29 October 2013

MicroTechnologies Announces ISO 13485:2003 Certification

MicroTechnologies achieves ISO 13485: 2003 certification for their quality management system. UL (Underwriters Laboratories), one of the world's leading certification bodies, recommended this certification.

To receive ISO 13485: 2003, an organization must demonstrate the ability to provide medical devices and related services that consistently meet customer requirements. "Achieving this certification is another step toward offering our medical device customers the best in class manufacturing expertise, facilities and quality certifications," stated Andrew Miclot, Executive Vice President of MicroTechnologies. "This continues our commitment to invest and support current and new medical device customers. We have already invested in equipment and a medical device contract manufacturing facility, including our new state-of-the-art clean room."

ISO 13485 is based on quality management principles to enhance organizational performance. These principles relate to customer focus, management, internal processes and external relationships. This international standard is globally recognized for establishing quality management systems that consistently meet customer and regulatory requirements for safe and effective medical devices.

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