NOBLE successfully passed the ISO13485:2016 medical device quality management system review on January 5th, 2022, and obtained the certificate on January 26th, 2022. Our company has taken a solid step towards the standardized management of medical devices.
With the joint attention and efforts of all employees, the company has carried out a lot of learning and internal improvement work in 2021. On the premise of ensuring that their own work is not affected, the task of system construction has been well completed, and everyone has been improved. The standardization awareness and internal management level.
The scope of this certification is "product design, production and sales of intense pulsed light therapy (for hair removal)", and will continue to add more product categories in the direction of smart care products.
The Chinese name is "Medical device quality management systems for regulatory purposes", and the English name is " Medical devices—Quality management systems—Requirements for regulatory purposes ".
Since medical devices are special products for saving lives, preventing and curing diseases, it is not enough to regulate only according to the general requirements of ISO9000 standard . The quality management system of device manufacturers has put forward special requirements, which has played a good role in promoting the quality of medical devices to be safe and effective.
The current version as of November 2017 is ISO13485:2016 "Requirements for Medical Device Quality Management Systems for Regulations", and the name and content have changed compared to the previous version.
NOBLE is a Sino-British joint venture awarded by the government as a "National High-tech Enterprise". We have two major business directions: “Smart Manufacturing” and “Care Products”. The “Smart Manufacturing” business specializes in providing customers with projects supporting services including parts machining and manufacturing.
NOBLE was established in 2012 and started with rapid prototyping and low volume manufacturing for innovative products. After years of hard work and development, NOBLE has gradually transformed from a precision parts machining and manufacturing enterprise with complete industrial chain supporting service capabilities, to a service-oriented enterprise that provides full support for customers' entire projects. We have accumulated rich experience and great achievements in various innovative fields such as intelligent care products, medical devices, automobiles & vehicles, robots, commercial spacecrafts, and automation equipment.
Our management is standardized, we have certifications of ISO9001-2015 and ISO13485-2016 and will soon obtain Production Permits for Medical Devices.
Our “Care Products” business focuses on fields of beauty care, health care, elderly care. We are a comprehensive entity enterprise with ability of independent R&D, production and sales.
Add: 3F, Building A, Zhengchangda Technology Park, Jian'an Road, Fuhai Subdistrict, Bao'an District, Shenzhen