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As a component manufacturer of medical devices, Well-Organized Quality Management System is the most essential matter for NCC. NCC is operated under the system which is qualified by Ministry of Health, Labour and Welfare Japan, Food and Drug Administration USA and ISO 13485:2003 Certification by TÜV SÜD Product Service in Germany.
As a parts manufacturer of medical devices, NCC examines its all processes by process validation for process control and process stability to achieve high quality level. The approaches NCC is always trying are for making all possible improvement as of today, as a company who has been engaged in the field for long time. Certification of Japanese Ministry of Health, Labour and Welfare For many years, NCC has approved by Japanese Ministry of Health, Labour and Welfare as a Medical Device Manufacturer even though a component manufacturer, who does not need to be approved, which means NCC stands on higher level than the other competitors. |
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FDA Registration
Since 1984 NCC has been registered in FDA in US as a component manufacturer of medical device. Our Quality Management System also meets requirements of CGMP 21 CFR Part 820 as ‘State of Control’ certified by Quality Audit conducted in 2003 March.
ISO 13485:2003
NCC’s Quality Management System was certified by TUV Product Service that it meets the requirements of ISO 13485:2003 in September 2005. NCC, a components maker for medical device, may be considered as the first company to be certified in ISO 13485:2003 in the field here as obtained the approval of the ISO13485:2003 as qualified manufacturer of stainless steel cannula for medical devices. As you know, ISO13485:2003 is international standard of Quality Management System which is specialized for Medical Devices and it requires more elements for Medical Devices than ISO9001:2000 is internationally well-known for Quality Management System.
NCC will continue improving to meet our clients’ requirements and to make every effort for manufacturing products, building and maintaining its system according to regulatory requirements for our clients to use our products without any anxiety.
Customer Support
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To make the best use of advantages of direct supply from manufacturer to clients, we commit to provide quickly our technical and quality support for our clients’ requirement using the latest communication tool such as Video conference system. |
FLOW CHART - from Inquiry to Service after the sales -
We have environmental control room, which conforms to a general standard of class 100,000 (ISO class8) for our inspection to ensure our products meet the requirements. Our inspection data is collected with our sophisticated measuring equipments and it is digitally conducted with PC.
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