St. Charles, MO – MW imaging, a third party Ultrasound company focusing on repair, servicing, maintenance, distribution and sales of diagnostic ultrasound systems, probes and parts has achieved ISO 13485:2016 certification for medical device and quality management systems. ISO 13485:2016 certification aligns with FDA regulatory guidelines and is an international standard that outlines the requirements for a quality management system specific to the medical device industry.
“MW Imaging’s commitment to quality has always been the foundation of our success, and obtaining ISO certification represents our continued commitment to quality” said Amber Sportsman, VP of Operations.
“We initiated this process a few years ago when we implemented our service management system and began the development of our training program. Forecasting where the industry was heading, we knew this would be one of the certifications we would need to achieve. Without sacrificing our daily activities, implementing a team effort was the catalyst to completing the ISO 13485:2016 certification” said Bob Grzeskowiak, President of MW Imaging.
ISO 13485:2016 is a quality management system standard that was developed by the International Organization for Standardization, which is an association of governmental and nongovernmental organizations from multiple countries. The ISO 13485 standard is utilized to certify quality management systems that focus on continuous improvement, customer satisfaction, and the active involvement of both management and employees in a process based approach.