Fabricación médica avanzada, controlada y confiable
Nuestra sala limpia ISO Clase 7 abarca 2.000 m², con temperatura, humedad y partículas en el aire monitoreadas constantemente para mantener condiciones estables para el moldeo de precisión.
Antes de la producción, se analizan las materias primas para determinar su fluidez y humedad. Durante la fabricación, medimos las dimensiones con sistemas de visión CCD, CMM y herramientas 2D. Los sistemas de medición se validan periódicamente y las calibraciones internas de laboratorio garantizan la trazabilidad completa de cada lote.
Moldeo por inyección automatizado ISO 13485
Nuestras 25 máquinas de grado médico, que van desde 40T hasta 180T, incluyendo sistemas Sumitomo y Zhafir de alta precisión, utilizan automatización robótica y accesorios personalizados para garantizar resultados consistentes. Escalamos eficientemente para proyectos de gran volumen, manteniendo la agilidad para procesos médicos especializados de bajo volumen.
FAQ
Is Weilan MFG an ISO 13485 injection molding supplier?
Yes. Our medical manufacturing operations are supported by an ISO 13485 quality management system for controlled medical device production. ISO 13485 injection molding helps establish documented processes, risk-based quality controls, traceability, and consistent records. Share your device classification, target market, and supplier-documentation requirements with the RFQ so we can confirm the exact quality and compliance scope for your program.
Do you provide cleanroom injection molding for medical devices?
Yes. Our 2,000 m² ISO Class 7 cleanroom provides controlled conditions for medical device injection molding. Temperature, humidity, and airborne particles are continuously monitored to support stable production. Cleanroom requirements still vary by component and intended use, so tell us whether your part needs controlled molding, assembly, packaging interfaces, bioburden controls, or other project-specific handling requirements.
What information is needed for a medical injection molding quote?
Send 3D CAD, controlled 2D drawings, resin grade, annual volume, order quantity, critical dimensions, cosmetic requirements, and the intended use of the component. Also identify the target market, sterilization method, cleanroom requirements, traceability needs, inspection plan, and required validation or quality documents. Defining these items during the RFQ lets us quote the correct medical-grade plastic molding process and documentation scope.
Can you help select medical-grade plastics for injection molding?
We can review material options against the molding process, geometry, performance needs, sourcing requirements, and expected production volume. For medical-grade plastics, your team should also define applicable biocompatibility, chemical resistance, sterilization, regulatory, and change-control requirements. Provide an approved resin specification when available; otherwise, share the application conditions so candidate materials and required supporting documents can be evaluated before tooling.
How do you control quality and traceability for medical plastic injection molding?
Before production, raw materials are checked for melt flow and moisture. During manufacturing, dimensions can be verified with CCD vision systems, CMM, and 2D measuring equipment. Measurement systems are regularly validated and internal lab calibrations support batch traceability. The final control plan, sampling level, critical dimensions, and record-retention requirements are agreed according to your component and quality documentation needs.
Can you support validation and documentation for medical device injection molding?
Validation and documentation requirements should be defined before quoting because they affect tooling, sampling, testing, schedule, and cost. Tell us whether you need first-article inspection, capability studies, process-validation protocols or reports, material certificates, lot traceability, inspection records, or customer-specific forms. Our team will review the requested deliverables and include the agreed scope in the project plan and quotation.
Can you handle both medical molded parts and device assembly?
Yes. We can combine medical device injection molding with mold manufacturing, sourcing, assembly, and agreed testing as part of a medical device contract manufacturing program. We also support specialized low-volume medical runs and automated high-volume production. Send the component drawings, BOM, assembly flow, test requirements, forecast, and regulatory responsibilities so we can define a clear scope and quotation.