PHILADELPHIA, PA, January 14, 2016 – ControlRad Systems announced today that is has achieved ISO 13485:2003 certification for its quality management system.
ISO 13485:2003 is an international standard that specifies requirements for a quality management system where an organization demonstrates its ability to provide safe, effective and reliable medical devices that consistently meet customer and regulatory requirements.
ISO 13485 is based on quality management principles that have been proven to enhance organizational performance. These principals relate to customer focus, organizational management, control of internal processes and external relationships that affect quality of a company’s products.
“We are proud to have achieved this high quality standard,” said Guillaume Bailliard, President and CEO, ControlRad Systems. “The effective quality management system is an important foundation as we continue to grow our business and prepare for the next quality and regulatory requirements to meet our customers’ needs.”
ControlRad is a privately-held medical technology company developing innovative products that dramatically reduce the lifetime risk of radiation exposure from fluoroscopically guided interventional procedures (FGIP) for patients and healthcare professionals. These products are designed to improve safety without compromising image quality or workflow. This is accomplished with an integrated set of proprietary components which optimize the X-ray beam to deliver optimal image quality in the clinically-relevant region of focus of the physician while maintaining appropriate resolution in the periphery. ControlRad is headquartered in Philadelphia and has engineering development facilities in Kfar Saba, Israel. For more information, visit www.controlrad.com.