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| Design & Development Process:
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| Product Concept |
At this stage Tianyi Medical work closely with our client in identifying the product requirements, specifications, intended use and any legal or regulatory requirements. A mock up of the overall product idea will then be drawn up to determine critical design features and manufacturing processes.
The target market for the product(s) along with its existing and potential competitors will also be identified at this stage.
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| Product Design & Process Development |
The purpose of this stage is to investigate the concept feasibility and develop or adapt a manufacturing process. It is critical to understand the product function in order to avoid unnecessary complications down the line.
A risk analysis will be carried out on all aspects of the product and its processes. The objective of this stage is to convert our client's requirements into a detailed product specification. This will include detailed C.A.D drawings from our engineers, component specifications, material selections and a detailed Bill of Materials. In conclusion this stage identifies the manufacturing process, assigns the necessary equipment, develops the necessary tooling and estimates the product cost(s).
A well conceived design and development process will ensure faster time to market, fewer redesigns and better client satisfaction. |
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| Prototyping |
At this stage we build and test experimental prototypes. This ensures quality and increases the level of communication between Tianyi Medical and our client.
By carrying out small scale testing it reduces development time, facilitates the manufacturing implementation process and highlights potential future system enhancements. |
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| Design Verification & Validation |
This stage verifies if the product design is consistent with the product specification. Validations are than carried out to ensure it meets our client's requirements.
Design testing is carried out to verify the following:
 Compatibility |
| Reliability |
| Biocompatibility |
| Sterilisation |
| Performance |
| Packaging | |
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| Process Validation & Design Transfer |
| Process validation and design transfer comprises of the activities involved in moving a product from the development engineering stage into the manufacturing stage. Manufacturing processes are established along with a detailed manufacturing plan outlining the facilities, equipment, materials, tooling and process flow layouts. |
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| Manufacturing Transfer |
Once the manufacturing process is validated and both quality and cost are acceptable, the process is transferred to production.
Production personnel will be trained-up
Product will be qualified
Training records will be drawn up
Product will be transferred to a manufacturing system
Product will be released into the market place |
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| Our overall design & development objective is to continuously provide excellent and innovative design solutions and processes while enhancing our own capabilities. | |
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