1. Confirmation and establishment of the project
Usually, after receiving the design requirements of medical devices from customers, industrial design companies will issue the project task book, formally establish the project and start the design and development work.
2. Planning of medical device design and development
After the project is approved, according to the specific design requirements, the corresponding design and development team is established, the design and development procedures are established, and ideas are put forward, including the functions, appearance, structure, materials, technology and production technology of medical devices.
3. Input content of design and development
On the basis of market research, put forward the function, performance, safety requirements and risk management requirements of the product according to the demand, improve the expected use, performance, efficacy and use requirements of the product, and form corresponding documents on the requirements of personnel, equipment, production environment, safety and reliability, applicable materials and service life after detailed examination, confirmation and approval.
4. Output of design and development
The design output must first meet the design input, and give or accept the technical requirements of the required materials, components and parts. Product standards, product drawings, parts list, production technology, process, production equipment, prototype, inspection procedures and methods, packaging and packaging identification shall be given, and the design and development shall be recorded.
5. Design and development review
Design and review is a systematic activity to ensure the suitability and effectiveness of design and development results, and whether the specified goals are achieved. Its purpose is to evaluate whether the results of design and development stage meet the requirements of design and laws and regulations, find out the existing problems, put forward measures to solve the problems, and avoid unqualified products in the early stage.
6. Verification of design and development
In order to ensure that the output of medical device product design and development meets the input requirements, the design and development are verified according to the planned arrangement. The contents of verification methods include: using different methods to design and verify design data or requirements; Compared with similar designs; Conduct prototype testing and demonstration; Self-test prototype; Ask a third party to test; Examination of documents, etc.
7. Confirmation of design and development
In order to ensure that the products can meet the specified applicable requirements or known expected use requirements, the design and development of medical device products should be confirmed according to the planned arrangement. This includes clinical evaluation, simulation comparison evaluation, performance evaluation and so on.
In addition, if necessary, design changes and change reviews, as well as more important reasons, requirements, standards, etc. It needs to be clearly put forward and the revised content needs to be reviewed.