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  • Team Introduction


    The professional consultant team of the company is composed of more than 20 people, mainly distributed in Shanghai, Guangdong, Wuhan and other places in China, and also has corresponding professional resources in Australia, North America and Europe. The consultant team is divided into European regulation department, Sino US regulation department, routine project department and international registration department. They are respectively responsible for consulting and counseling of European CE certification, guidance of 510k declaration and factory inspection in the United States, guidance of China's medical device registration and production license, and international registration services. Among the consultants, 35% have master's degree or above, and 25% are overseas students. Some consultants have working experience in well-known certification institutions, and some consultants have working experience in well-known medical device enterprises. The technology leader of the company is also a IEC evaluation expert. He has won the IEC 1906 prize in 2017 and has been reported by the National Commission for Discipline Inspection. Our consultant team is able to provide consulting and counseling services for enterprises, which are combined with production practice and integrated with regulations and standards.


    A professional technical team is the core competitiveness in the compliance consulting industry.

     

    SUNGO is committed to building a global team of professional consultants. In order to provide our customers with localized services, we are committed to cultivating and developing our consultant teams around the world. At present, we have professional consultant teams in China, Australia, Canada, the Netherlands and the United Kingdom. The consultant teams in China are located in the Yangtze River Delta, the Pearl River Delta and the Central China, which can conveniently provide services for customers across the country.

     

    The consultant team members all have a solid academic foundation and strong professional background. Among them are experts from the International Standard Organization, senior directors of internationally renowned certification bodies, quality and R&D managers of internationally renowned medical device enterprises, and consultants with North America RAC qualifications. The consultant teams are able to provide consulting services for customers in Chinese, English, Dutch, Italian and German.

     

    The person in charge of technology of the company had served as a senior management (Asia Pacific Region) in an internationally renowned certification body for a long time; he is also an review expert of the International Electrotechnical Commission (IEC), participating in the preparation and revision of standards, and in the review and qualification of certification bodies; he obtained the IEC 1906 Award in 2017 and was reported in real name by CNCA.

     

    Our consultant teams can provide enterprises with customized services, and provide consulting and counseling services that are integrated with regulations and standards based on the actual production situation of the enterprises.

    Raymond Luo
    Shanghai, China Technical Director of SUNGO Master of Engineering He had worked for the Asia Pacific Headquarters of a world-renowned certification body for a long term. As the Assistant President and the Certification Director of the Asia Pacific Headquarters, he took charge of the global product certification and the business of the Asia Pacific Branch. He also serves as the certification reviewer and the senior trainer of the IEC. He was awarded the IEC 1906 Award in 2017 due to his contribution to the IEC, which was reported by the Certification and Accreditation Administration of the People’s Republic of China. He has a good command of the European and the U.S. laws and regulations on medical devices and is qualified for the MDD/MDR reviewer of many notified bodies. He led the QSR820 counseling of SHINVA Medical Instrument and the QSR820 client audit of Wego Group, and led the close-out of Warning Letter and Import Alert which was firstly completed by a Chinese competitor.
    Ivy Wang
    Shanghai, China Senior Consultant of SUNGO Bachelor of Linguistics She had served as the Regional Review Manager of the International Department of a world-renowned certification body and been responsible for supervising, managing and guiding certification affairs of the overseas branch office. She has rich experience in passing the FDA factory inspection of foods, drugs, medical devices and cosmetics. She is familiar with GMP laws and regulations of different fields and the audit thought and method of FDA reviewers. She provides customized counseling for enterprises with different bases, which always works well with little effort.
    Christina Cui
    ShangHai, China Senior Consultant of SUNGO Bachelor of Engineering She had served as the reviewer of a notified body for the EU medical device regulations. She has participated in the CE certification audit for Class III medical devices of famous Chinese medical device companies for many times and accumulated tremendous successful cases. Both the overseas study experience and the review experience in the notified body contribute to her study on the new EU laws and regulations. She is good at providing the technical service and training for the EU laws and regulations on medical devices (clinical assessment report and MDD/MDR technical documentation).
    Adrian Zhong
    Shanghai, China Consultant of SUNGO Bachelor of Engineering Adrian Zhong has many years of experience in manufacturer and regulatory consulting industry, is familiar with the standard requirements of medical device quality management system, and is good at tailoring a full range of consulting and counseling services for the enterprises.
    Daisy Gong
    Wuhan, China Lead Consultant of SUNGO Bachelor of Engineering She had performed QMS-related work in a medical device manufacturer for a long time. She also has the second party audit experience of a world-renowned certification body and the lead auditor qualification certificate. She is good at assisting the enterprise in QMS diagnosis and guiding and supporting the QMS establishment and optimization of the enterprise. She is proficient in the operation and implementation requirements of QMS and has in-depth study on various quality tools.
    Tao Zhu
    Sungo senior consultant, Bachelor of engineering, 10 years of medical device industry experience, more than 6 years of medical device design and development, quality management experience, has served as R & D project manager, registration and regulatory department manager, quality manager, management representative. Familiar with the design and development process, verification and validation of production and service processes, including product development, registration and marketing, establishment and operation of quality system, familiar with ISO 13485, ISO 9001, qsr820 and other quality systems, and rich experience in medical device product design and development and quality management. Good at medical device research and development, product registration and quality system regulations and other related work.
    Mandy Wu
    Wuhan, China Senior Consultant of SUNGO Bachelor of Engineering. With ten years of work experience, Mandy Wu has served several well-known medical device companies, and has unique insights and experience in quality system management. Wu is familiar with the production management process and management system implementation requirements and regulations of active and passive products. Wu has rich experience in accepting the audit, and has repeatedly helped customers quickly establish corresponding plans and successfully pass the audit.
    Yajun He
    Wuhan, China, Consultant of SUNGO Bachelor. Yajun He has many years of experience in the regulatory consulting industry, is a national registered QMS auditor, is familiar with European medical device regulatory requirements, and has coached nearly 100 enterprises in CE technical documentation of medical devices.
    Hanbing Wu
    Shanghai, China, Senior Consultant of SUNGO Bachelor of Engineering. Hanbing Wu has more than ten years of work experience in the medical device and testing industry, is proficient in the testing standards of active medical device products, has successfully provided CE certification or testing consulting services for hundreds of medical device enterprises, and is good at coordinating various events of the applicants in the consulting and counseling process and efficiently assisting the enterprises to complete the certification. In these aspects, Wu has accumulated rich experience.
    April Geng
    Shanghai, China, Lead Consultant of SUNGO Master of Engineering。 April Geng has many years of experience in CFDA registration of medical devices, and rich experience in quality control and intellectual property patent declaration. Geng is proficient in the registration declaration of passive and active devices, diagnostic reagents and software products, document writing, and system construction. Geng is good at providing customized counseling for enterprises with different bases.
    Xiangyu Wang
    Shanghai, China Consultant of SUNGO Bachelor. Xiangyu Wang has many years of experience in manufacturer and regulatory consulting industry, is familiar with the standard requirements of quality management system and ISO13485, and is good at providing customized consulting and counseling services for enterprises with different bases, implementing system certification consulting schemes, and guiding the enterprises to establish and improve their management systems.
    Amanda Sun
    Shanghai, China, Consultant of SUNGO Bachelor of Science. Amanda Sun had served in an internationally renowned certification body, been engaged in technical management, and been responsible for the supervision, management and guidance of certification affairs in various offices. She is a national registered QMS and EMS auditor, with rich audit experience in various industries, and many years of management system counseling experience. She is good at providing customized counseling for enterprises with different bases, coordinating various events of the applicants in the counseling process and efficiently assisting the enterprises to complete the certification. She has coached nearly 100 enterprises in international registration affairs and CE technical documentation of medical devices.
    James Liu
    Wuhan,China, Consultant of SUNGO Bachelor of Engineering. He has ten years of experience in the medical device industry. He has served as a quality regulatory manager in a large medical company for a long time, and is fully in charge of the compliance registration of medical device. He is particularly expert at the international registration of active products of medium and high risk. Being familiar with the design and development of software and hardware, he is capable of providing professional constructive guidance.
    Yana Zhang
    Netherlands, overseas support consultant of sungo, Bachelor of Management. She has been working and living in the Netherlands for a long time. She is familiar with the medical device regulations in Europe and the Netherlands, and is in charge of the technical services of sungo Netherlands and the direct contact with the local authority.
    Bill Gan
    Shanghai,China. laboratory testing expert of SUNGO, Master of Engineering. He has served as the technician of a laboratory for a long time. He is proficient in regulation, standards and norms in the field of medical device testing.He is good at providing customers with sterile equipment packaging verification, cleaning, disinfection and sterilization verification programs.
    Hedy Cao
    Shanghai,China, The backbone of SUNGO microbial detection technology, Bachelor of Engineering, She has 5 years of working experience in microbiological testing laboratories of a listed company. She is familiar with testing standards, and possesses advanced testing qualifications.
    Eva Lee
    Chile. Senior Consultant of SUNGO Master of Management . She had served as a senior auditor and the Regulatory Affairs Manager of a world-renowned certification body and been responsible for the study of certification and accreditation techniques and international standards. She has a profound study on international certification and accreditation as well as regional certification laws and regulations. She has a good command of the U.S. laws and regulations on medical devices and drugs, and has rich experience in QSR820 counseling for medical devices, GMP counseling for drugs, 510K application counseling and close-out of Warning Letter and Import Alert in the U.S.
    L. Y. Ji
    Canada. Senior Consultant of SUNGO Master of Science. L. Y. Ji had served as the Quality and Regulatory Affairs Manager of a famous medical device enterprise in Canada and been responsible for the global registration and pre-market approval of high-risk medical devices. Ji is proficient in the U.S., Canada and the EU laws and regulations on medical devices, and especially good at the pre-market approval of medical devices in Canada. Ji has rich counseling experience in 510K files and CE MDD and MDR technical documentation of medical devices and in vitro diagnostic devices.
    Lucas Jin
    Australia. Technical Consultant of SUNGO Master of Engineering. He has worked and studied in Austria for a long term. He is familiar with the requirements of Australian laws and regulations on medical devices. He is responsible for SUNGO’s technical service for TGA registration and contacting TGA directly.
    Jackei Zhu
    United Kingdom. Technical Consultant of SUNGO Master of Engineering. Jackei Zhu has worked and studied in the UK for a long term. Zhu is familiar with the requirements of the UK and European laws and regulations on medical devices. Zhu is responsible for SUNGO’s technical service for the UK and European registration and contacting the Food and Drug Administration of relevant countries directly.
    Hugh Lee
    Shanghai, China. Consultant of SUNGO Bachelor. Hugh Lee has many years of experience in service and regulatory consulting industry, is familiar with the standard requirements of quality management system and ISO13485, and is good at tailoring a full range of consulting and counseling services for the enterprises.