Common medical device product design and development process:
1. Project confirmation and project establishment
Often, after receiving the customer's medical device product design needs, the industrial design company will issue a project task letter to formally set up the project, and start the design and development work.
2. Planning of medical device design and development
After the project is established, according to the specific design requirements, the corresponding design and development team is formed, the design and development procedures are established, and the vision is put forward, which contains many aspects of the medical device's function, appearance, structure, material, process, production technology and so on.
3. Design and development of the input content
Based on market research, according to the needs of the product's function, performance and safety requirements and risk management requirements, to improve the product's intended use, performance, efficacy, use requirements, requirements for personnel, equipment, production environment and other requirements, safety and reliability, applicable materials, service life, and other aspects of the content of the product, after a detailed review, After detailed examination, confirmation, approval and the formation of the corresponding documents.
4. Output of design and development
Design output first needs to meet the content of the design input, need to give the required materials, components, parts of the technical requirements out or acceptance criteria, give the product standards, product drawings, parts lists, production processes, processes, production equipment, prototypes, inspection procedures and methods, packaging and packaging marking and other details, and make good design and development records. development records.
5. Design and development review
Design and review is to ensure that the design and development of the results of the appropriateness of the effectiveness of the system activities carried out to achieve the specified objectives. Its purpose is to evaluate whether the results of the design and development phase to meet the design requirements, whether to meet the requirements of laws and regulations, to identify existing problems, put forward measures to solve the problem, to avoid product failure at an early stage.
6. Verification of design and development
To ensure that the output of medical device product design and development to meet the input requirements, based on the planning arrangements for the verification of design and development. Validation methods include: adopting different methods to design and validate the data or requirements of the design; comparing with similar designs; making prototype tests and demonstrations; self-testing of prototypes; requesting third-party testing; and evaluating documents.
7. Confirmation of design and development
To ensure that the product meets the specified applicable requirements or the requirements of the known intended use, the design and development of the medical device product should be confirmed in accordance with the planned arrangements. This includes clinical evaluation, comparative simulation evaluation, and performance evaluation.
In addition, if necessary, design changes and change reviews are required, and the reasons, requirements, and criteria for the changes need to be clearly stated, and the changes need to be reviewed.