Providing agents for medical device manufacturers from product process design, clinical trials, product testing, clean workshop design and construction to enterprise registration; Production license and product registration certificate; Comprehensive medical regulatory solutions. existent
Consulting services include: formulating product standards;
The filing and registration of medical device manufacturing enterprises of category I (including newly-opened and initial registration, expiration change and extension);
Applications for production licenses of Class II and Class III medical device manufacturers (including new start-up, change and renewal upon expiration); Establishment and operation guidance of medical device quality management system; Medical device registration inspection; Guidelines for clinical trials of medical devices; Medical device product registration (including initial registration, change registration and expiration replacement); Design guidelines for purification plants; Medical device process verification; Medical device business enterprise declaration form; Medical device advertising statement; Medical device website filing; Medical device management planning; Medical device procurement consultation; Guide to regulations and technical standards of medical device industry; Medical device system, product certification consultation, etc.
In order to further standardize the business consulting process and improve the consulting service level, the company has always adhered to the talent strategy and recruited talents, laying a good foundation for having a professional technical support team. At the same time, in the process of operation, it has established close cooperative relations with relevant scientific research units, clinical medical institutions, universities and enterprises, and has sufficient information resources of regulations and technical standards.
With our experience, through high-quality and standardized consultation process management, we can help enterprises to avoid detours, improve the efficiency of declaration and reduce the risk of declaration failure.
Grow with customers * * *, making Guangdong Yikaimeng Medical Device Information Consulting Co., Ltd. a trusted professional consulting organization for enterprises.
The growth of the company is inseparable from your guidance and support! Our company will provide honest, professional, meticulous and efficient services to meet your needs!
Legal Representative: Luo Huina.
Date of establishment: 20 14-06- 14.
Registered capital:100000 yuan.
Location: Guangdong Province
Unified social credit code: 914401kloc-0/304393368g.
Operating conditions: cancellation of enterprises
Industry: leasing and business services
Company type: limited liability company (natural person investment or holding)
Personnel size: 50-99 people
Enterprise address: Room 30 1 A, Zone A, 3rd floor, Dongzhan Road1Dongzhan Comprehensive Building, Tianhe District, Guangzhou (for office use)
Scope: Commodity information consulting services; Trade consulting services; Enterprise management consulting services; Investment consulting services; Medical equipment rental service; Medical research and experimental development; Market research services; Material science research and technology development; Retail of medical supplies and equipment (excluding drugs and medical equipment); Non-licensed medical device business (that is, medical devices that can be operated without applying for a Medical Device Business License), including Class I medical devices and Class II medical devices that can be operated without applying for a Medical Device Business License as stipulated by the state;
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