Analysis of Risk Factors in Production Process of Mechanical Detachment Coil and the Focus on Site Quality Management System Inspection
One of the most effective therapies for aneurysm is to use mechanical detachment coil.However,the adverse events occurd by product quality problems during the surgical process are at high level.Through the analysis of risk factors in personnel,machine,material,process,environment during production,this article focus on the site inspection in the mechanical detachment coil production process.It is also a good guidance for medical device inspectors in inspecting mechanical detachment coil.
mechanical detachment coilrisk factorsfocusquality system inspection