Research On Improvement Of Product Quality Control Of UDI

Medical Devices, especially the implantable medical devices, will impact to patient’s health and safety directly. In order to ensure the safety of medical devices in use, the government supervision of medical devices is also more and more strictly, the constant introduction of relevant laws and regulations to strengthen the medical instrument traceability. US FDA in September 20,2013 announced the new medical device regulatory requirements, medical devices shall be marked the global Unique Device Identification (UDI). After the implementation of UDI rules, medical devices will be more likely to be tracking, monitoring, and speed up the recall. Medical device manufacturing enterprises have to apply the unique device identification requirements in medical device to comply the regulations. This thesis takes Johnson & Johnson Medical Suzhou Company as an example to study the application of Unique Device Identification in production to improve the product traceability.The thesis has 5 parts:Firstly, introduced the importance of traceability requirements to medical devices and the new regulations of Unique Device Identification to require the improvement of traceability, and the Unique Device Identification can bring benefits for the medical device industry. Took Johnson & Johnson Medical Suzhou Company as a case study, introduced the background of the company.Secondly, analyzed the traceability problems and risk of Johnson & Johnson Medical Suzhou Company, explains the necessity to improve the traceability of product of medical devices and production quality control.Thirdly, detailed analyzed the improvement approach of Johnson & Johnson Medical Suzhou Company and the advantages of Unique Device Identification (UDI), research on how to improve the product traceability. And introduced the two-dimensional code technology and its characteristics, combined with the characteristics of products and production in Johnson & Johnson Medical Suzhou Company illustrated the two-dimensional code technology can effectively help the implementation of the Unique Device Identification (UDI) to improve the product traceability and production quality control.The fourth part described in detail the Johnson & Johnson Medical Suzhou Company implement Unique Device Identification (UDI) process to improve product traceability and production quality control, and analyzed the effect of the implementation of the Unique Device Identification (UDI) as well.The fifth part summarized the key finds found in the implementation of the Unique Device Identification and pointed out the direction of the next step research.The last part, detailed described the implementation of Unique Device Identification With 2-D barcode technique in production in Johnson & Johnson Medical Suzhou Company and production process optimization with Unique Device Identification as well.In this thesis, summarized the study of the implementation of Unique Device Identification in production in Johnson & Johnson Medical Suzhou Company to improve the product traceability and production quality control and also provide the reference to the other companies in the industry implementing the Unique Device Identification.