FOR IMMEDIATE RELEASE: 03/29/2023
MW Imaging Announces ISO 13485:2016 Recertification
MW Imaging Corp, a leading Ultrasound Parts, Probes, Systems and Service provider, is proud to
announce the achievement of ISO 13485:2016 recertification for its business operations based out of
St. Charles, MO. MW Imaging’s facility was audited by DEKRA Certification, Inc., an accredited ANAB Certification body. They were presented with their certificate on March 21, 2023. The St. Charles facility repairs Ultrasound Probes, Systems and equipment from all leading manufacturers. The company has implemented standardized in-house processes and testing methods that ensure a high quality of repairs for their products and services.
ISO 13485:2016 is the world’s most widely recognized medical device quality management standard, developed and published by the International Organization for Standardization (ISO) for Medical Device companies. It provides a framework to establish a rigorous quality management system that aligns with FDA regulatory requirements laid out in 21CFR, Part 820. It predominantly focuses on mandatory regulatory requirements, compliance, evidence-based decision-making, risk management and accountability across all organizational processes. It ensures that medical devices placed on the market are safe and effective.
“The core values of MW Imaging have always been to achieve the highest standards in all that we do. This recertification is a direct result of the collective efforts of the MW Imaging team. Without the dedication of our employees, this achievement would have been impossible. These efforts have led to improved efficiency, productivity and most importantly customer satisfaction. We believe this certification demonstrates our dedication to quality, continuous improvement, patient safety and both employee and customer satisfaction.” said Amber Sportsman, Vice President of Operations / Quality Manager.
MWI Imaging has been certified since March 2020, and has been audited yearly for conformance to ISO 13485:2016 standards despite the challenges of the COVID 19 Pandemic.
Founded in 1995, MWI is a leading provider of Ultrasound Parts, Probes, and Services. To find out more about our products, systems, services and our focus on Quality please visit our website at www.mwimaging.com.