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2021
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Stages of the Medical Product Mold Design Control Process
Medical product mold design control process: the goal of this process is to ensure that the final product is effective, safe and meets the needs. Local regulations can be met; ensure prototype conforms to concept. This helps the design process of medical product mold manufacturers.
Medical product moldDesign control process:
The goal of this process is to ensure that the final product is effective, safe and meets the needs. Local regulations can be met; ensure prototype conforms to concept. This helps the design process of medical product mold manufacturers.
The medical product mold design control process includes the following steps:
Design Input
The design inputs define the performance criteria and functional requirements of the medical device. Design input is the most time-consuming part of design control, and effective documentation is the key to the ultimate success of the product development process.
Design input includes: obtaining all functions, performance, and safety; setting user requirements and usage intentions; and ensuring that the design input is clear and objective. The design input is stated in a manner that allows proof or counter-evidence; product marking, traceability, manufacturing, packaging and inspection procedures; design input affects not only regulatory requirements, but also design output, design verification, success or failure of the final product.
Design output
The design output, like the formulation of the instrument, consists of the parts, components, modules, inspection procedures, material requirements, and test protocols required to manufacture the instrument. The design output is the final result of integrating the design input into the comprehensive production plan of the device. Design output and design input are continuous loops. The process completes successfully when the design output finally agrees with the design input. The team must refer to the design input documentation when creating the output. Design output includes the instrument itself, technical documentation, risk analysis, all studies and user guides for or related to the instrument.
Design Research
Companies should review all designs, find errors and defects, and make improvements. There are generally two types of design studies: failure mode analysis and error mode analysis. Failure mode analysis is the process of identifying risks that may cause potential problems with the machine. Error pattern analysis scans every part and component of the device, finds potential errors, determines the cause, and proposes solutions. These results must be recorded in the Design History File (DHF).
Design Verification
Repeated testing of new medical equipment is very important because potential failures and safety risks can cause more serious losses.
The purpose of design verification is to demonstrate that the design output meets the design input requirements. Testing, analysis and inspection can be documented here to prove that the design of the medical device meets the customer's requirements and meets the design requirements.
Design changes
Design change refers to the change of instrument design. Product development is a very iterative process. As the product development process progresses, it may be necessary to go through this phase multiple times. The enterprise shall establish and maintain procedures for identification, documentation, verification, review and approval prior to implementing design changes. Verify and validate that the issues that need to be addressed for this design change have actually been addressed. Confirm whether the change has been approved and whether the change will cause a new problem. Ultimately, major design changes must be notified to the regulatory authority and the equipment re-licensed.
Design transfer: Design transfer is an important stage in the product life cycle. According to FDA quality system regulations, manufacturers must complete the following steps to complete the design migration process: establish and maintain procedures to correctly convert instrument designs to production specifications; ensure that product designs are converted to production technologies and methods; and transfer product medical product mold designs to manufacturing environments. A complete set of processes that coordinate multiple tasks simultaneously. With past experience, good program operation and detailed review are the key to successful conversion. When production is outsourced to other manufacturers, medical product mold design transfers may fail due to well-communicated issues. Differences in corporate culture, corporate resources, quality systems, and professional opinions before design will increase the risk before design.
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