Position

Necessity Certification (Beijing) Co., LTD.——Founder and General Manager

Professional Experience

National Registered Auditor, senior legal, registration and standards consultant; Senior legal, internal auditor, registration, system audit professional lecturer;

Served as a full-time auditor for 7 years and a part-time auditor for 6 years in Beijing Guoyixie Huaguang Certification Co., Ltd.;

Lecturer of system and regulations of Beijing Guoyixie Huaguang Certification Co., Ltd., senior consultant of active, passive, sterile, implant and IVD products;

Industry experience

He has 27 years of experience in the medical device industry, once served as quality director and operation director of domestic active, aseptic and IVD medical devices(Class III products) enterprises.He has Worked as senior auditor in Beijing Hua Guang Certification of Medical Devices Co.,(Abbreviation for CMD) for 13 years, with audit experience in 500 medical device enterprises.He is professional lecturer of medical device regulation & standards; Active, passive, sterile, implanted, IVD medical devices products senior consulting teacher, with consulting experience in 200 medical device enterprises, among which there are more than 10 MDD/MDR system and FDA/QSR 820 system.