Keenman Successfully Obtained Huaguang Certificate Of Quality Management System For Medical Device
Release time:
2022-08-12
As the first start-up enterprise in Wuxi to focus on innovative orthopedic instruments and digital sports medicine products, Wuxi Keenman Manufacturing Technology Co., Ltd. (referred to as "Keenman") has successfully passed the system assessment organized by Beijing Huaguang Certification of Medical Device Co., Ltd. and obtained ISO9001 & ISO13485 quality management system certification after nearly three years’ efforts and growth.
As the first start-up enterprise in Wuxi to focus on innovative orthopedic instruments and digital sports medicine products, Wuxi Keenman Manufacturing Technology Co., Ltd. (referred to as "Keenman") has successfully passed the system assessment organized by Beijing Huaguang Certification of Medical Device Co., Ltd. and obtained ISO9001 & ISO13485 quality management system certification after nearly three years’ efforts and growth.
This is a milestone achievement of Keenman with extraordinary significance! It means that Keenman has taken a solid step as a technology innovation company focused on the research and development, production, and sales of minimally invasive orthopedic medical products. The five series of products that have passed the system certification this time are the first phase products of Keenman, which focuses on digitalization of medical operations. It is expected to obtain two type II and three type III NMPA certificates and a Medical Device Production License by early 2023. At the same time, multiple innovative medical device products collaborated with well-known medical institutions in the province have been preliminarily tested by doctors through clinical trials on corpses to meet their expected uses. After design improvements, they will be certified in 2022.
In addition, multiple products from the second phase and the first domestically patented automatic tendon suturing device are also advancing in an orderly manner. After the product is launched, it is expected to bring more industry competitiveness and high value market share to Keenman.
Keenman is committed to becoming an outstanding leading brand in the invention of minimally invasive orthopedic innovation device in China, providing perfect and effective treatment solutions for doctors and patients, and allowing healthy exercise to accompany them for a lifetime.
Helping people love their sports better!
KEENMAN - A technology innovative company focused on the research and development, production, and sales of minimally invasive orthopedic innovative medical device products.
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