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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.

Sandra Jiang

Responsible person for new project development. Familiar with medical device regulations of EU, US, Australia, Canada and Saudi Arabia, and be able to provide multiple plans and supporting to clients in order to be accommodate local requirement. Till now, several manufacturers have been put their devices to overseas under the help of us.

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.

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.

Luna Hu

Consultant, Master of Wuhan University, more than 10 years of work experience in the compliance industry, rich experience in on-site counseling, focusing on the United States medical device regulatory services.

Kelly Xu

Consultant, Fudan University, majoring in bioengineering. Specialised in IVD product regulation and product development consulting, with rich experience in product development and registration.

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.

Andrew Wang

Consultant, professional direction for medical device quality management system guidance and technical document preparation, has quality management work experience in Microport Neurotech, and has completed dozens of ethylene oxide sterilization process confirmation of implantable or interventional medical devices.

Ariel Xiang

Consultant,&PM，specializing in US and EU medical device regulations.She is good at 510k application counseling and MDR Notified Body certification.

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.

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.

Claire Liu

Senior consultant, professional direction for the EU medical device regulations service, with years of registration and R&D experience at top 50 medical device company nationwide, has multiple successful certification experiences for MDR, the products involve Class IIa, IIb, III active and non-active devices, skilled in guiding and writing technical documentation related to product design and development, verification and validation, risk management, etc.

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.

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.

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.