Position

Nasevi Certification (Beijing) Co., Ltd. - Manager of Training Department

Career experience

National registered auditor, former full-time auditor of Beijing National Medical Equipment Huaguang Certification Co., Ltd.; auditing more than 300 enterprises.

Industry experience

Senior expert in the medical device industry, served as deputy secretary-general and member of the National Technical Committee for Medical Device Quality Management and General Requirements Standardization (SAC/TC221), engaged in standard formulation and revision for 13 years, and participated in 20 medical device industry standards as the main drafter It is the first drafter of the YY/T 0287—2017 idt ISO13485: 2016 "Requirements for Medical Device Quality Management System for Regulations" standard; YY/T 0595—2020 "Medical Device Quality Management System YY/T 0287" —The second drafter of the 2017 Application Guidelines standard.

YY/T 0316 "Application of Medical Device Risk Management to Medical Devices", YY/T 0664 "Life Cycle Process of Medical Device Software Software", YY/T 1406.1 "Medical Device Software Part 1: YY/T 0316 Applied to Medical Devices" The main drafters of "Guide to Software", etc.;