Project establishment: According to the annual product […]
Project establishment: According to the annual product development plan, or customer requirements, or the results of market surveys, the project is established to describe the economic significance of the project. Due to the high operating cost of medical devices, low-value, low-volume products are difficult to maintain the company's operations.
Assignment of tasks: clarify the various stages of product development, as well as the responsibilities and division of personnel at each stage, the time required for research and development, and resource requirements. It is important to appoint a project manager. The project manager is responsible for the product life cycle and is also the main supervisor of the project development process.
Development plan: The design and development task is compiled by the R & D department, which includes project description, model planning, structural composition, functional requirements, main performance parameters, quality requirements, drawings and processes, and design verification / confirmation requirements , Requirements for production equipment, requirements for the preparation of technical documents, and risk management activities. The content of the task book should be comprehensive and specific, so that the project can proceed smoothly.
Design input: market research report or customer requirements, applicable national / industry standards, applicable laws and regulations, product intended use, product structure composition and function / performance, software, safety assessment of applicable standards, risk management reports and control measures. The design input includes the content in the design development task book. The design input documents shall be reviewed.
Design output: product technical requirements, specifications, production drawings, bill of materials, process flow diagrams, production processes, inspection processes, quality requirements for outsourced parts, procurement requirements, product packaging requirements, identification, traceability requirements, production environment requirements . And other materials used for product registration, including: test reports (safety / performance / EMC / biocompatibility / sterility, etc.), product performance studies, expiration studies, packaging and transportation studies, software studies, disinfection / sterilization studies , Clinical evaluation, etc.
The design output shall meet the requirements of the design input. The design output files shall be reviewed. From the perspective of product registration, finding a well-known brand product model in the market for comparative research and development, compiling the later research data, and passing the review of the registration data will all be more effective.
Design verification: Generally, samples and tests of the whole machine or component will be carried out during the research and development process. After the technical information is completely completed, the production and inspection of the prototype can be carried out and then sent to a third party for inspection (as the basis for design verification). Prototypes are generally produced in more than three units, one of which is sent for inspection, and the other can be used for research testing such as expiration date. Design verification should be reviewed.
Design conversion: According to the needs of the registration system inspection, all types of products should be produced. This small batch production can be used as a basis for design conversion to verify the company's ability in product production. Thereafter, in principle, no major changes can be made to drawings and processes. Design transitions should be reviewed.
Design confirmation: Conduct clinical trials or clinical evaluations. Clinical trials are best entrusted to a professional consulting firm. Design validation shall be reviewed.
Design changes: Design changes will be involved in each stage of the design, including changes to drawings, bills of materials, processes, technical requirements, procurement requirements, specifications, identification, etc., as well as rectification of problems found during testing. Major changes should be considered for retesting and verification. Design changes should be reviewed.
Device documents: All technical documents of medical devices should be kept, including drawings, processes, technical requirements, instructions, standards, regulations, etc. Refer to ISO13485.
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