WS Audiology first hearing aid company to receive EU MDR certification
Under the MDR, manufacturers have strict obligations to monitor the quality, performance and safety of devices. Also, existing devices which have been CE marked under the current EU Medical Device Directive (MDD) must be recertified to abide by the new MDR requirements.
The certification process at WS Audiology, with hearing aids and related software in scope, started with on-site audits in October & November of 11 sites in Europe, the US, China and Singapore. During these audits the company's new quality management system was reviewed by notified body TÜV Süd to ensure compliance to the EU Medical Device Regulation.
"The WS Audiology quality management system was put in place in record time following the merger of Widex and Sivantos on March 1, 2019," said Thomas Hies, Chief Quality and Regulatory Officer for WS Audiology.
"We have seen a tremendous cross-functional effort to build a new Quality Management System for WS Audiology," he added. "We have not only created a state-of-the art quality system by combining the best of Widex and Sivantos, but we are also very proud to be the first hearing aid company to meet the standards of the challenging European Medical Device regulation."
WS Audiology CEO Eric Bernard said: "We are truly pleased with this very important achievement by the team, especially in view of the fact that we were going through a merger process when these audits were performed."
About WS Audiology
Formed in 2019, through the merger of Sivantos and Widex, WS Audiology combines over 140 years’ experience in pioneering the use of technology to help people with hearing loss hear the sounds that make life wonderful. We are active in over 125 markets and employ more than 10,000 people worldwide. Our broad portfolio of leading hearing related products and services generates annual revenues of around €1.7 Billion. WS Audiology is privately owned by the Tøpholm and Westermann families, as well as funds under the management of EQT. As a global leader, our ambition is to unlock human potential by making wonderful sound part of everyone’s life.