NCE provides internal audit services to evaluate clients' management systems. We audit the organizational structure and operational structure of the client company to check whether it meets relevant standards and requirements. Document the results in the report while highlighting opportunities to improve and ensure that the organization is more effectively prepared for certification audits.

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Our supplier audit service includes detailed analysis of the entire supply chain to ensure that it is always open and transparent to the company and customers. The second party audit service evaluates whether the supplier meets the established requirements. Identifying gaps and improving opportunities is crucial for professional supplier management. The NCE supplier audit service can provide valuable support for the selection and evaluation of existing and new suppliers.

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Based on the standardized process audit, we evaluate the flexibility and efficiency of processes, sub processes and company systems. These audit results provide a basis for your future decisions in quality management. In addition to the single process audit aimed at preventing and correcting process defects, we also provide continuous improvement measures and routine process audit services.

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The manufacturer's audit and evaluation meet the relevant standards of specific industries. Are the products and licenses adopted by the manufacturer and the communication of contract content transparent enough? With in-depth expertise in requirements related to your industry, our audit experts will evaluate all applicable aspects.

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Article 17 of the regulations on the supervision and administration of medical devices (Decree No. 739 of the State Council of the people's Republic of China on February 9, 2021): the drug regulatory department that accepts the registration application shall review the safety and effectiveness of the medical device and the ability of the registration applicant to ensure the safety and effective quality management of the medical device. The drug regulatory department that accepts the registration application shall transmit the registration application materials to the technical evaluation institution within 3 working days from the date of accepting the registration application. After completing the technical review, the technical review institution shall submit the review opinions to the drug regulatory department that accepts the registration application as the basis for approval. If the drug regulatory department that accepts the registration application considers it necessary to verify the quality management system when organizing the technical review of medical devices, it shall organize the verification of the quality management system. Basis of quality system verification

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NCE provides key audit services in the field of medical device compliance and service quality. Using the verified research design, we carry out customized key audits according to the scope of customer authorized investigations. Our key audit work is supported by NCE technical experts and industry experts.

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In order to ensure the quality of the company's services and internal processes, control measures need to be taken regularly. In the case of insufficient regulatory requirements and standardized evaluation methods, the list of additional evaluation standards customized for relevant companies has proved to be valuable. Our NCE service experts have senior experience in the field of audit and certification, and can assist customers in this task. They paved the way for the professional development of the standard list of new companies and the optimization of the existing list.

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