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.
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.
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.
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.