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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

Guangzhou, 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.

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.

Jarvis Wu

Guangzhou, China, Master of Science, Consultant of SUNGO. Jarvis Wu has served as R&D engineer at Chinese Academy of Science, and has many years of experience in manufacturer and regulatory consulting industry. He is familiar with U.S. medical device regulations, FDA 510(k) submission process and reviewer’s opinions. Furthermore, Jarvis has completed 510K submissions over 15 cases in less than one year. His 510K products have includes medical masks, surgical gowns, isolation gowns, syringes, insulin needles, electric scooters, electric wheelchairs, and dental handpieces, etc.

Lisa Pu

Shanghai, China,Consultant of SUNGO Bachelor.Guiqin Pu has many years of experience in medical company and regulatory consulting industry, is familiar with the standard requirements of quality management system, and is good at providing the consulting service for the EU laws and regulations on medical devices.

Bruno Jiang

Shanghai, China.Consultant of SUNGO, Bachelor of engineering, Bruno Jiang has served as an auditor in a well-known third-party certification authority in the United States. He has many years of experience in the regulatory consulting industry and is familiar with the quality management system and ISO13485 standard requirements, He is good at customizing comprehensive consulting and counseling services for enterprises.

Charlie Wong

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.

April Peng

Wuhan, China.Consultant of SUNGO, Master degree of Engineering. She has many years of consulting experience, familiar with the requirements of the ISO series of standards, She specializes in building quality management systems in the medical field and writing technical documents based on EU regulations, and provides customized consulting and coaching services for companies with different bases.

Sandra Jiang

Consultant of Sungo, Bachelor of Linguistics, who had served as senior consultant for a foreign-invested enterprise for many years. Know well of medical device regulations of different regions and countries, such as EU, the US, Switzerland, India, etc, she is able to provide various plans and supports for customers importing their products to overseas.

Suikka Lee

Shanghai, China,Consultant of SUNGO Bachelor of Engineering. Suikka Lee has many years of experience in the regulatory consulting industry, is familiar with the regulatory requirements of medical devices, and is good at providing UDI application ideas based on enterprise product, and providing international registration and technical document counseling services for many enterprises.

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.

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.

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.

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.

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.

Chris Chang

Hefei,China,The technical backbone of SUNGO Laboratory,Bachelor of Engineering.He has 6 years of laboratory testing and management experience, once served as the technician of a laboratory.He is familiar with the relevant regulations, standards and specifications of the testing field of assistive product and the packaging and transportation verification of medical devices.

Betty Ruan

Supervisor of SUNGO Shanghai Laboratory, Bachelor of Engineering, more than 5 years of large-scale laboratory work experience and project management experience. Good at laboratory project management.

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.