Research On The Improvement Strategy Of Medical Device Clinical Trial Quality Management System In Sigma Company

Clinical trial of medical devices is the key stage of Class II and Class III medical devices research and development.It is the clinical verification phase that determines whether medical devices can be registered for human use.Under the environment of increasingly strict supervision and supervision of clinical trials of medical devices,Medical device sponsors,hospitals,contract research organizations and other relevant parties need to improve the quality management system as soon as possible.At present,the research is limited to establish and improve the quality management system from the perspective of hospital medical device clinical trial institutions and ethics committee.Based on the perspective of medical device contract research organizations,this paper discusses how to solve the quality management problem of medical device clinical trial industry under the increasingly stringent regulatory requirements,so as to ensure the registration and listing of test medical devices entrusted by the sponsor.This paper starts from the perspective of Sigma Company’s employees,combines "man,machine,material,method and environment",the main factor affecting product quality in the theory of total quality management,and combines questionnaires and interviews from five aspects: organizational structure of company quality management,quality management activities,management personnel level,document management operation process and project management assessment.Investigated the current quality management status,problems and suggestions of the company..The main problems existing in the current quality management system are as follows:the lack of internal quality control and project assistant personnel in the enterprise organizational structure;In the quality management activities,there are mainly unreasonable schedule and the implementation of three-level quality control is not in place.Lack of expertise in the medical and clinical departments and inexperience in middle management programs;The source of the document is prone to error,easy to save the loss and error problems;There are some problems in personnel quality management assessment,such as incomplete assessment method and unsatisfactory tracking of assessment effect.The reasons for the problems are as follows: the personnel department and the business department of the company do not know enough about the operation process of clinical projects;The sponsor does not pay enough attention to the quality management of the project;The company’s internal training system is not perfect;The company has not formed a strict document management standard operating procedures;The project quality assessment system is not open,transparent and enforceable.The main problems existing in the current quality management system are as follows: the lack of internal quality control and project assistant personnel in the enterprise organizational structure;in the quality management activities,there are mainly unreasonable schedule and the implementation of three-level quality control is not in place.;lack of expertise in the medical and clinical departments and inexperience in middle management programs;the source of the file is prone to error,easy to lose and error in the process of saving;there are some problems in personnel quality management assessment,such as incomplete assessment method and unsatisfactory tracking of assessment effect.The reasons for the problems are as follows: the personnel department and the business department of the company do not know enough about the operation process of clinical projects;the sponsor does not pay enough attention to the quality management of the project;the company’s internal training system is not perfect;the company has not formed a strict document management standard operating procedures;The project quality assessment system is not open,transparent and enforceable.The solution given in this paper needs to combine quality assurance and quality control theory,total quality management theory and quality risk management theory.Mainly from the following five aspects to improve the quality management system: establish internal quality control department and project assistant positions in the personnel organization structure,optimize project plans,develop communication channels and strictly implement project management activities in the process of project quality management activities,improve the training system of new employees,daily department sharing,monthly training and annual training,from the document generation,circulation,recovery to improve the document operation process and quality management assessment system improvement.The above measures to improve the company’s current quality management situation and establish a sound medical device CRO quality management system to provide corresponding countermeasures.