医疗器械单一审核程序中质量管理体系检查工作的介绍

Introduction of Quality Management System Audit in Medical Device Single Audit Program

医疗器械单一审核程序中关于质量管理体系检查部分的内容涵盖了多个国家监管机构的检查要求,具有极为重要的参考意义。该文简单概述了医疗器械单一审核程序中质量管理体系检查的流程和内容。同时,初步探讨了对我国监管和检查工作的一些启示,供相关机构参考。

The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.