Team Introduction

The company now has more than 20 expert teams with more than 10 years of experience in the medical device industry, and several professional service personnel have the qualifications of national registered auditors for medical devices, chief auditors of EU notified bodies, and medical device regulations training lecturers. With exceptional expertise, knowledge is delivered through ongoing training, coaching, industry information sharing and performance tools to help clients comply with regulations. Once we establish a cooperative relationship with you, we will visit you regularly to promote the company to continuously meet the requirements of regulations and standards, so that you can more confidently accept regular and irregular assessments from industry regulatory authorities and customers, and win trust in the industry.

Chen Jianjun

Beijing Huaguang Taihe Medical Technology Service Co., Ltd. - General Manager

◆ Bachelor of Applied Electronic Technology, China University of Science and Technology Management;

◆ National registered auditors, senior regulations, registration, standards consultants; senior regulations, internal auditors, registration, system audit professional lecturers;

◆Beijing National Medical Equipment Huaguang Certification Co., Ltd. has been a full-time auditor for 7 years and a part-time auditor for 6 years;

◆Beijing National Medical Equipment Huaguang Certification Co., Ltd. system and regulations lecturer, senior consultant for active, passive, sterile, implantable, IVD products;

◆ 15 years of experience in the medical device industry. He has served as the quality director and operation director of three types of active, sterile and IVD enterprises in China. He has rich practical experience in combining laws and regulations, theory and practice, and can talk about the teaching process of daily management and application.

Audited about 500 companies and consulted about 200 medical device companies, including more than 10 EU MDD/MDR systems and FDA/QSR820 systems.

Zhang Bing

Deputy General Manager and Technical Director

◆ Suzhou Medical University undergraduate clinical medicine;

◆ National registered auditor, senior regulation, registration, standard consultant; senior regulation, internal auditor, registration, risk management, system audit, special process verification lecturer;

◆Beijing National Medical Equipment Huaguang Certification Co., Ltd. has been a full-time auditor for 8 years and a part-time auditor for 5 years;

◆ Special lecturer of Beijing National Medical Equipment Huaguang Certification Co., Ltd., expert in sterility, implantation and IVD products;

◆ Participated in the compilation of Beijing Municipal Medical Device Process Water, Clean Workshop Environment Guidelines, and In Vitro Diagnostic Reagent Production Quality Management Specifications;

◆ 27 years of experience in the medical device industry, served as the quality director of three types of active and sterile enterprises in China; has rich practical experience in combining laws and regulations, theory and practice, and can apply daily management in the teaching process.

Audited about 600 companies and consulted about 200 medical device companies, including more than 20 EU MDD/MDR systems and FDA/QSR820 systems.

Milan English

Training manager

◆ Hebei University Bachelor of English

◆ Tianjin University Master of Business Administration MBA

◆ National registered auditor, former full-time professional of Beijing National Medical Equipment Huaguang Certification Co., Ltd., GMP inspector of Beijing Municipal Food and Drug Administration; more than 200 audited enterprises.

◆ Senior expert in the medical device industry, once served as the 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 industries as the main drafter The formulation and revision of the standard is the first drafter of YY/T 0287—2017 idt ISO13485: 2016 “Requirements for the Use of Medical Device Quality Management System for Regulations”; YY/T 0595—2020 “Medical Device Quality Management System YY/T” 0287—2017 Application Guide, the second drafter of the 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 The main drafters of "Guidelines for Device Software", etc.;

Wang Shaohua

Deputy General Manager (Distinguished Expert)

◆ Dalian Railway University Undergraduate Department of Chemistry Industrial Analysis Major

◆ National registered auditors, senior regulations, registration, standards consultants; senior regulations, internal auditors, registration, innovation approval professional lecturers;

◆Beijing National Medical Equipment Huaguang Certification Co., Ltd. has been a full-time auditor for 8 years and a part-time auditor for 9 years;

◆ Special lecturer of Beijing National Medical Equipment Huaguang Certification Co., Ltd., expert in sterility, implantation and IVD products;

◆ 20 years of experience in the medical device industry, serving as the deputy general manager of three types of sterile and implantable production enterprises in China; board secretary/deputy general manager of listed companies;

Audited about 600 companies and consulted dozens of medical device companies, including more than 10 EU MDD/MDR systems and FDA/QSR820 systems.

Shi Tongling

Registration Manager

◆ Master of Harbin University of Commerce Major: Fermentation Engineering

◆ 8 years working experience in medical equipment

◆ Worked in in-vitro diagnostic reagents and diagnostic equipment manufacturers, quality system leader and manager representative, mainly responsible for the quality system construction and registration of diagnostic reagents and diagnostic equipment.

◆ 3 years of product registration service, dozens of product registration experience, mainly responsible for products such as diagnostic reagents, active radio frequency, sodium hyaluronate, intraocular lens and protective products;

◆ National Registered Intern Auditor:

Participate in ISO13485:2016 (YY/T 0287-2017), ISO9001-2015 (GB/T19001-2016) quality system certification audit;

Li Wencui

Audit manager

◆ Changchun University of Technology Undergraduate Major: Biotechnology

◆ 10 years of experience in microbiological inspection and management of sterile, IVD, and implanted enterprises, and served as microbiological inspector, quality manager, manager representative, etc.;

◆ National registered auditor, 3 years full-time auditor experience of Beijing National Medical Equipment Huaguang Certification Co., Ltd.;

◆ Senior microbiological technical inspection engineer and lecturer; skilled in operating microbiological inspection equipment, mastering testing principles and methods;

◆ Leading and planning the verification and confirmation of key processes and special processes; compiled the system documents of aseptic, implant, IVD and other enterprises during the service work process, and guided the enterprises to pass the assessment of the Food and Drug Administration. Audited more than 200 companies.

Liu Xia

system engineer

◆Beijing Pharmaceutical Group Staff University College Major: Medical Laboratory

◆ 8 years working experience in medical equipment; from 2011 to 2019, he worked in Beijing Jina High-tech Medical Equipment Co., Ltd. Position: The manager of the quality inspection department is mainly responsible for the inspection of raw materials and semi-finished products and finished products, the microbial inspection of purified water and products, the environmental control of clean workshops, and the preparation of relevant verification documents;

◆ Currently engaged in the training of medical device product inspectors (sterility, implantation, IVD enterprise inspectors), with rich experience in practice and teaching;

◆ National Registered Intern Auditor:

◆ Participate in ISO13485:2016 (YY/T 0287-2017), ISO9001-2015 (GB/T19001-2016) quality system certification audit;