Quality Magazine

MicroE Systems Receives ISO 13485 Certification

November 14, 2011

BEDFORD, MA-MicroE Systems now has the capability to manufacture optical encoders for medical industry customers who require ISO 13485 traceability of key components. The company’s manufacturing facility in Bedford, MA, achieves the traceability via its recent ISO 13485:2003 certification.

The certification requires MicroE Systems to demonstrate and maintain a comprehensive quality management system that includes traceability of the encoder systems produced and the components used in its manufacture. To achieve the certification, MicroE Systems proved its quality and tracking management system to an accredited, independent auditing organization. The traceability certification supports customers designing MicroE Systems’ linear and rotary encoders into patient-critical applications in surgical systems, diagnostic systems, hand-held medical devices, hospital instrumentation and life sciences equipment.

The ISO 13485 certification is an enhancement to MicroE Systems' existing ISO 9001:2008 certification.

MicroE Systems manufactures a wide range of high-performance encoders, including linear, rotary, miniature PCB-mount and low-power models. Available resolutions range from 5 microns to 1.2 nanometers (linear) and 3000 to 268 million counts (rotary).