Shandong Bandao operation shadowless lamp

2022-05-29

I believe many people have heard of the LED surgical shadowless lamp. According to the market demand, there are many kinds of shadowless lamps. What is their design process? Today, Shandong Bandao will give you a brief talk on the following general development process of LED surgical shadowless lamp


1. determine new projects and project initiation




In general, Shandong Bandao medical industry design department will issue the project assignment, announce the project initiation, and start the design scheme and development design after receiving the design requirements of customers for medical products.




2. Design and development of LED operation shadowless lamp




After the project is approved, according to the requirements of the actual design scheme of the LED surgical shadowless lamp, organize the corresponding elite team for the design and development of the LED surgical shadowless lamp, and clearly put forward the concept according to the design, development and design process, including the function, appearance, structure, materials, processing technology, production technology and other aspects of the medical instruments.




General steps of LED surgical shadowless lamp product design and development




Led operation shadowless lamp product design




3. typing contents of design scheme and development design




On the basis of market research, the functions, characteristics, safety regulations and risk control regulations of LED surgical shadowless lamp products are clearly put forward according to requirements. Several aspects shall be considered: the provisions on the main use, characteristics, functions, use regulations, personnel, mechanical equipment, working environment, safety factor and stability, available raw materials, service life, etc. of the product, and the corresponding documents shall be formed after detailed review to determine the accuracy.




4. output of design scheme and development design




Design output is the content that first meets the design input. The design scheme must provide the technical standards or acceptance rules for the required raw materials, components and accessories, and provide the product implementation standards, commodity engineering drawings, components and accessories details, production process flow, the whole process of processing, production line equipment and other details, samples, test procedure flow and mode, packaging and packaging identification, and record the design scheme and development design.




General steps of LED surgical shadowless lamp product design and development




Led operation shadowless lamp




5. design scheme and development design review




Design scheme and review is a systematic activity to better ensure the applicability and effectiveness of the design scheme and development design results, and whether the required overall objectives are achieved. Its purpose is to evaluate whether the design scheme and the results of the design stage comply with the provisions of the design scheme and relevant laws and regulations, find out the existing deficiencies, and clearly put forward the countermeasures to solve the difficulties, so as to prevent the commodity failure in the primary stage.




6. verification of design scheme and development design




In order to ensure that the output of medical device product design and development design meets the requirements, the design scheme and development design shall be verified according to the allocation of scheme planning. Verification methods include: designing and verifying design data or requiring different methods; Compare with similar designs; Carry out prototype test and demonstration; Self check the prototype; Ask a third party to conduct the test; Review documents, etc.




Shandong Bandao led operation shadowless lamp product design




Medical device product design




7. determination of design scheme and development design




In order to ensure that the product can meet the required available terms or understand the expected main use terms, the design scheme and development design of the medical device product shall be determined according to the distribution of the design scheme. This includes clinical medicine review, simulation comparison review, characteristic review, etc.




In addition, if necessary, design scheme change and change review shall be carried out to clearly explain the change reasons, regulations, specifications, etc., and the change contents shall be reviewed.