Study on the Construction of Quality Risk Assessment Indicators for Medical Device Manufacturing Enterprises
Objective:Using the Delphi method to construct a quality risk assessment index framework for medical device manufacturing enterprises,in order to achieve hierarchical classification management of medical device manufacturing enterprises,thereby improving inspection efficiency and rational allocation of regulatory resources.Methods:After preliminary literature research and on-site investigation,a preliminary indicator framework was formulated,and a survey questionnaire was prepared for expert consultation.Expert opinions were sorted and analyzed to determine the final indicator framework.Results:A risk assessment index framework for medical device manufacturing enterprises has been constructed,covering 5 primary indicators(production and sales capacity,quality control level,scientific research ability,variety situation,regulatory situation)and 32 secondary indicators,and the weights of each indicator have been determined.Conclusion:The quality risk assessment indicators for medical device manufacturing enterprises are scientific and practical,and can serve as important reference tools for daily supervision of medical device manufacturing enterprises.
Delphi methodmedical devicequality riskgrading and classification
万方数据
维普
