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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).
    Liyuan Liu
    Shanghai, China Senior Consultant of SUNGO Bachelor of Engineering/Master of Management Liyuan Liu has more than 20 years’ technical quality-related experience in the medical device industry. As the Chief Engineer of the company, Liu directly takes charge of the whole process of medical devices from R&D to marketing, including compliance registration and marketing approval. Liu is proficient in the technical service for the European laws and regulations on medical devices (MDD/MDR/ISO13485), statistical techniques and quality management tools. Liu has rich experience in providing audit service for clients.
    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.
    Crystal Cai
    Crystal Cai Guangzhou, China Lead Consultant of SUNGO Master of Engineering She had worked for a large famous medical device company in China for a long term and been responsible for the R&D and compliance registration of medical device products. She was responsible for the international and domestic registration of active and sterile medical devices with medium or high risk in various categories. She is good at the international registration of medical devices with medium or high risk. The international registration regions cover major economies and regions in the world, such as the Europe, the U.S., Australia, Canada and Japan. She can provide integrated counseling which combines the medical device management system with laws and regulations of each country.
    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.
    Lisa Zhang
    Lisa Zhang Wuhan, China Lead Consultant of SUNGO Master of Engineering Lisa Zhang had worked in a well-known domestic pharmaceutical enterprise, held positions as heads of R&D, project management and overseas compliance, and completed the full cycle of multiple active and passive high-risk products from design and development to overseas listing. She is good at counseling on regulations related to European market access, and is familiar with medical device market access in the United States, Brazil, Japan, South America and Middle East. With professional project management capability, she can provide customers with the most appropriate access plans with practicality.