Research On The Establishment Of MY Medical Device Company Quality Management System

With the scale of medical consumer segments such as medical beauty and stomatology exceeding 100 billion,the market of such medical device industry has gradually entered a mature stage.At the same time,the National Medical Products Administration issued a new Order 739 on the supervision and management of medical devices in 2021,which clearly strengthen the supervision of medical device registrants.The new measures of all aspects have important impact on medical device production and operation enterprises.These stricter regulatory policies put forward higher requirements for the quality management system of start-up medical device manufacturers.MY medical device company is a start-up private company engaged in the operation of oral medical device-related products.Its main business includes products such as invisible orthodontic braces.To rapidly carry out process iteration,expand the production capacity of invisible orthodontic braces to seize the market,and at the same time meet the compliance requirements of ISO13485 "Medical Device-Quality Management Systems-requirements for regulatory purpose" and Order 739 "Medical Device Supervision and Management Regulations" to obtain the new registration certificate of the new production site from the district medical products Administration,it is an important strategic direction of MY company.This thesis takes MY company as the object of analysis.On the one hand,starting from the current situation of its quality management system,it analyzes the status of the quality management system documents system that has been built;On the other hand,the performance data of the quality management system of the same products of its group company were investigated and analyzed on the spot,including the audit results related to the registration examination,the first yield rate,rework rate and customer feedback data of the same product.The gaps between criterion and MY company current situation were found by bench marking,the main problems of the quality management system of MY group company were found by using data statistical analysis methods such as Plato analysis,and the root cause of the main problems were found by fish bone analysis.To help MY company quickly build an appropriate,sufficient and effective quality management system,this thesis uses the process method,according to the requirements of the registration system verification of Class II medical devices by the district medical products administration,that is,the "Medical device good manufacturing practice"(hereinafter referred to as the "GMP for medical devices"),ISO13485 "Medical DeviceQuality Management Systems-requirements for regulatory purpose",considering gaps and main issues,to put forward the quality management system construction scheme of MY company;At last,this thesis puts forward various safeguard measures to ensure the success of the quality management system of MY company.Through the research in this thesis,we can help MY company build a medical device quality management system that meets the requirements,accelerate the acquisition of Class II medical device qualification,improve the company’s quality management level,and make company’s product quality and enhance company’s competitiveness improved continuously.Meanwhile,it also provides more patients with safe and effective medical device products,provides reference for the establishment of medical device quality management system for start-up enterprises,and contributes to the vigorous development of China’s medical device industry.