What is included in the validation of the design and development of in vitro diagnostic reagents

Including the verification of analytical performance, real-time stability, bottle opening stability, transportation stability, etc. Registration detection is the ultimate validation.

Because most of the materials are from the folk, although it provides rich materials for the creation of "Romance of the Three Kingdoms", it also brings huge pressure to the writer. When they enter the text, they are accompanied by the infiltration of different ideas and different aesthetic tastes. However, folk sentiment and the spirit of good history are not always the same, and may even conflict with each other, which poses a severe test to the writer's creation.

Luo Guanzhong's greatness lies in the proper handling of the relationship between folk emotions and the spirit of good history, and creating a world of art with great inclusiveness. [5] The historical works of the Three Kingdoms not only provide the basic material and historical framework for "Romance of the Three Kingdoms", but also directly affect the creative mode and basic tendency of the historical consciousness represented by the historical consciousness and the official history. The spirit of truth-seeking and facsimile and the consciousness of the world are the basic characteristics of the culture of historians, which are embodied in the compilation of historical books, which require the compilers to adopt an objective attitude, and at the same time attach importance to the summarization and exploration of historical experience and lessons, so as to achieve the goals of "information management" and education.

These characteristics have been well reflected in "Romance of the Three Kingdoms". [5]

My answer is as follows: The design of the diagnostic test mainly includes group A, number B sets up the experimental group and the control group C, and observes and records the contents as follows: Experimental design in a broad sense refers to the knowledge of the general procedures of scientific research, which includes a series of contents from the formulation of questions, the formation of hypotheses, the selection of variables, etc., to the analysis of results, and the writing of **.

It shows the researcher an overview of how to conduct scientific research and tries to determine the whole process of research. Narrow Narrow Experimental Design refers specifically to the implementation of a planning plan for experimental treatment and the statistical analysis related to the planned program. The narrow design of experiments focuses on the section from how to establish statistical hypotheses and draw conclusions.

Personnel Requirements:

1. Legal representative: original ID card and original academic certificate, or no academic certificate, provide the original household registration book (the household registration book is marked with academic qualifications), personal resume;

2. The person in charge of the enterprise: the original ID card and the original academic certificate (college degree or above), personal resume;

3. Person in charge of quality: original ID card and original academic certificate [bachelor's degree or above in laboratory science or related majors], engaged in medical device quality management related work for more than three years], personal resume;

4. The person in charge of the quality organization: the original ID card and the original academic certificate [college degree or above related majors (medical devices, biomedical engineering, medicine, pharmacy, nursing, **, laboratory science, health inspection and quarantine technology and other medical-related majors), relevant quality work experience of more than three years], resume;

6. The physical examination report can be replaced by a health certificate (Class D);

Product requirements: three types of product information 1, business license, 2, product registration certificate, production product registration form of the manufacturer 3, medical device business license or production license 4, power of attorney.