Technical Handbook for Implementing VA/VE in Medical Device Plastic Molding for Design Developers
This is a book for designers that compiles the technical know-how of medical plastic injection molding from a company equipped with permits for medical device manufacturing, ISO 9001 certification, and injection molding facilities with clean rooms of Class 10,000 or lower.
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basic information
1. Basic Knowledge of Plastic Injection Molding What is Plastic Molding What is Plastic Injection Molding Molds in Plastic Injection Molding 2. Basic Knowledge of Medical Devices and Parts What are Medical Devices Classification of Medical Devices in the Country International Classification of Medical Devices Clean Rooms Used for Medical Devices 3. VA/VE Examples of Medical Plastic Injection Molding Key Points for Cost Reduction in Product Design Key Points for Reducing Defect Rates in Product Design Key Points for Improving Usability in Product Design Key Points for Mold Design Key Points for Material Changes and Sterilization Processes
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Applications/Examples of results
Medical plastic molded products, etc. - Anesthesia needle core - Ultra-thin tube cap - Thin-walled tube - Reagent cartridge - Thin-walled syringe
Company information
We provide plastic medical devices of assured quality. - Medical Device Manufacturing and Sales License Number: 11B2X10048 - Medical Device Manufacturing Registration Number: 11BZ200082 - ISO 13485 certified company - Precision molding in a clean room with a class of 10,000 or lower Shinwa Kogyo Co., Ltd. has been honing its plastic molding and mold manufacturing technologies since its establishment in 1974. Throughout this process, we have actively developed services such as 3D-CAD compatibility, product design, flow analysis, and mold design, providing our customers with services that go beyond just contract processing. Additionally, through our dealings with clients in the medical industry, we have been involved in numerous medical products, including the establishment of an in-house clean room with a class of 10,000, obtaining ISO 13485 certification, and acquiring licenses for medical device manufacturing and sales, as well as custom molding machines. We will solve all your concerns regarding medical plastic products with VA/VE proposals based on flow analysis and mold design technology by certified plastic molding specialists from the design stage. Please feel free to consult with us.