Etratech achieves ISO 13485 quality certification medical devices
Etratech Inc., Burlington ON, a global leader in the design, development and manufacture of advanced electronic controls and control systems for major multinational companies, has achieved its ISO 13485:2003 certification through quality registrar BSI Canada. This standard certifies that Etratech has established a quality management system that demonstrates its ability to meet the stringent requirements of customers in the medical equipment and device market.
“We have worked hard for nearly six months to achieve this certification, which demonstrates our commitment to manufacturing nonsurgical medical products in a manner that complies with or exceeds industry standards,” says Zaid Salim, director of global quality assurance at Etratech.
Etratech designs and manufactures electronic controls for international OEMs across a broad spectrum of industries including automotive, HVAC and security. The addition of ISO 13485 to its impressive list of ISO and TS certifications reinforces Etratech’s commitment to quality and service. In fact, Etratech is one of the few companies in Ontario to have achieved both ISO 13485 and TS 16949, placing it among the highest quality manufacturing facilities on the country.
“We’re very proud to have achieved ISO 13485, and we’re looking forward to serving the medical equipment and devices market,” says Michael Desnoyers, president and CEO of Etratech. “Etratech’s dedication to the highest quality standards in both manufacturing and service levels is truly the foundation of our company. This achievement is really the perfect cap to our 25th anniversary year.”
Etratech is also registered to ISO/TS 16949:2009, ISO 9001:2000 and ISO 14000 by quality registrar BSI.