As a technical professional industrial design company, there are strict quality supervision regulations for the design scheme and development and design steps of medical devices, due to the high efficiency and quality related to the design and development of diagnosis and treatment products. The following and everyone share the general steps of medical device product design, development and design.

1. Determination of new projects and project establishment
Generally, after receiving the customer's medical product design requirements, industrial design companies will issue a project task book, announce the project establishment, and start the design plan and development and design work.
2, medical device design and development design plan.
After the project is established, according to the actual design requirements, a corresponding design and development elite team is established, and the concept is clearly put forward in accordance with the design, development and design procedures, which includes the role, appearance, structure, materials, processing technology, and production of medical devices. Technology and other aspects.

3, design plan and development design of the key content
On the basis of market research, the function, characteristics and safety regulations and risk control regulations of the product are clearly put forward according to the requirements. It needs to be considered to a large extent: the main purpose, characteristics, functions, application regulations of the product, regulations on staff, machinery and equipment, working environment, safety factor and stability, available raw materials, service life and other aspects of the content, to go through the detailed review, confirmation, accurate after the corresponding documents.
4. Output of design scheme and development design
The design output is the first content design plan to meet the design input. The technical standards of the required raw materials, components, and components must be given or accepted rules, and the product implementation standards, commodity engineering drawings, component details, and production process flow are given., The whole process of processing technology, production line equipment, samples, testing procedures and methods, packaging and packaging identification, etc., and make a record of the design plan and development design.

4. Output of design scheme and development design
The design output is the first content design plan to meet the design input. The technical standards of the required raw materials, components, and components must be given or accepted rules, and the product implementation standards, commodity engineering drawings, component details, and production process flow are given., The whole process of processing technology, production line equipment, samples, testing procedures and methods, packaging and packaging identification, etc., and make a record of the design plan and development design.
5, design plan and development design review.
The design plan and review is a systematic activity carried out to better ensure the applicability and effectiveness of the design plan and the results of the development design, and whether it achieves the required overall goal. Its purpose is to comment on whether the design plan and the results of the design stage meet the provisions of the design plan, whether it meets the provisions of relevant laws and regulations, find the existing deficiencies, clearly put forward countermeasures to solve the difficulties, and prevent the goods from not passing through the customs in the initial 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 of typing, the design scheme and development design are verified according to the distribution of scheme planning. The verification methods include: designing and verifying the design data or requirements in different ways; comparing with similar designs; making prototype tests and demonstrations; self-testing the prototype; requesting third-party testing; reviewing documents, etc.

7, design plan and development design determination.
In order to ensure that the product can meet the requirements of the available provisions or already know the estimate of the main use of the provisions, should be based on the design of the distribution of the design of the medical device product design and development design to determine. This includes clinical medical review, simulation comparison review, feature review and other levels of content.

In addition, if necessary, design changes and change reviews need to be carried out. More appropriate reasons, regulations, specifications, etc. must be clearly pointed out, and the content of the changes must also be reviewed.