ISO 13485 Authentication Cleanroom Compatible Medical Components Plastic Parts¹

Product Description Product DescriptionFactory_IntroductionShun Hing Industrial International Limited operates cleanroom-compatible manufacturing facilities with ISO 13485:2016 certification for medical device production. Our cleanroom environment meets ISO 14644 Class 8 standards with specialized protocols for contamination control and sterile manufacturing. Our cleanroom capabilities include specialized material handling, contamination-free processing, and comprehensive validation protocols. With dedicated cleanroom production lines and trained personnel, we provide medical-grade components for pharmaceutical, biotechnology, and medical device applications requiring sterile manufacturing.Product_Specific_DetailsOur cleanroom-manufactured components meet stringent cleanliness and biocompatibility requirements for medical and pharmaceutical applications. Advanced processing techniques ensure contamination-free production with comprehensive documentation and traceability. Specialized capabilities include sterile packaging compatibility, biocompatibility validation, and comprehensive cleanliness testing. Our components undergo rigorous validation including particulate testing, biocompatibility assessment, and sterility validation. Applications include pharmaceutical packaging, medical device components, laboratory consumables, and biotechnology equipment parts. Detailed Photos Product ParametersProduct_NameMaterialProcessing_MethodToleranceCertificationApplicationsLead_TimeMOQPEEK Engineering Plastic Parts for SurgeryMedical Grade PEEK (PEEK 450G, PEEK 450CA30)CNC Machining, Injection Molding±0.005mmISO 13485:2016,IATF 16949:2016,ISO 9001:2015Spinal Implants, Surgical Instruments, Orthopedic Devices3-6 weeks500 PiecesCOC Engineering Plastic Parts for Medical TestingMedical Grade COC (Cyclic Olefin Copolymer)Injection Molding, CNC Machining±0.01mmISO 13485:2016,IATF 16949:2016,ISO 9001:2016Diagnostic Equipment, Laboratory Instruments, Microfluidics2-4 weeks500 PiecesMedical Parts for Heart SurgeryMedical Grade PC, PEEK, POM, SiliconeInjection Molding, Insert Molding±0.01mmISO 13485:2016,IATF 16949:2016,ISO 9001:2017Heart Valves, Catheters, Surgical Instruments4-8 weeks500 PiecesMedical Parts for Eye Pressure MeasurementOptical Grade PMMA, PC, COCPrecision Injection Molding±0.005mmISO 13485:2016,IATF 16949:2016,ISO 9001:2018Tonometers, Pressure Sensors, Optical Windows3-6 weeks500 PiecesOral Care Plastic PartsFood Grade ABS, PP, TPE, SiliconeInjection Molding, Overmolding±0.02mmISO 13485:2016,IATF 16949:2016,ISO 9001:2019Electric Toothbrushes, Water Flossers, Dental Devices2-4 weeks500 PiecesHealthcare Plastic Parts (Shaver & Hair Dryer)ABS, PC/ABS, PP, TPE, Flame Retardant PlasticsInjection Molding, Overmolding±0.05mmISO 13485:2016,IATF 16949:2016,ISO 9001:2020Electric Shavers, Hair Dryers, Grooming Devices3-6 weeks500 PiecesSkin Care Electronic Product Plastic PartsMedical Grade ABS, PC, Silicone, TPUInjection Molding, Overmolding, Insert Molding±0.02mmISO 13485:2016,IATF 16949:2016,ISO 9001:2021Facial Devices, LED Therapy, Microcurrent Devices4-8 weeks500 PiecesEarphone Plastic PartsABS, PC, PA, TPU, Conductive PlasticsMicro Injection Molding, Insert Molding±0.01mmISO 13485:2016,IATF 16949:2016,ISO 9001:2022Wireless Earbuds, Headphones, Audio Accessories2-4 weeks500 PiecesSmart Glasses Plastic PartsOptical Grade PC, PMMA, TR90, Carbon Fiber ReinforcedPrecision Injection Molding, Insert Molding±0.005mmISO 13485:2016,IATF 16949:2016,ISO 9001:2023AR Glasses, VR Headsets, Smart Eyewear4-8 weeks500 PiecesElectronic Product Components (Charger & Bluetooth)Flame Retardant ABS, PC, PA, Conductive PlasticsInjection Molding, Insert Molding±0.02mmISO 13485:2016,IATF 16949:2016,ISO 9001:2024Chargers, Power Adapters, Bluetooth Devices2-4 weeks500 PiecesProduct Housing and Structural PartsABS, PC/ABS, PP, PA, Glass Filled PlasticsLarge Part Injection Molding±0.05mm (small features), ±0.1mm (large parts)ISO 13485:2016,IATF 16949:2016,ISO 9001:2025Electronic Enclosures, Appliance Housings, Industrial Covers4-8 weeks500 PiecesAutomotive IATF 16949 Certified Plastic PartsAutomotive Grade ABS, PP, PA66+GF, PC/ABS, POMInjection Molding, Insert Molding±0.01mmISO 13485:2016,IATF 16949:2016,ISO 9001:2026Interior Trim, Exterior Parts, Under-Hood Components6-12 weeks500 PiecesPrecision Micro-Molded ComponentsMedical Grade Plastics, Engineering Plastics, Specialty PolymersMicro Injection Molding±0.005mmISO 13485:2016,IATF 16949:2016,ISO 9001:2027Medical Devices, Electronics, Precision Instruments4-8 weeks500 PiecesCleanroom Compatible Medical ComponentsMedical Grade PC, COC, COP, PEEK, SiliconeCleanroom Injection Molding±0.01mmISO 13485:2016,IATF 16949:2016,ISO 9001:2028Pharmaceutical, Medical Devices, Laboratory4-8 weeks500 PiecesHigh-Performance Fiber Reinforced ComponentsCarbon Fiber Reinforced, Glass Fiber Reinforced, Hybrid CompositesCompression Molding, Injection Molding±0.02mmISO 13485:2016,IATF 16949:2016,ISO 9001:2029Aerospace, Automotive, Industrial Structural6-12 weeks500 Pieces Company Profile  FAQ Shun Hing FAQ - Frequently Asked QuestionsManufacturing & ServicesQ1. What manufacturing services does Shun Hing provide?A1: We offer comprehensive manufacturing services including precision tooling, plastic injection molding, machining parts, product assembly, In-Mold Labeling (IML), surface treatment, and complete project management from design to delivery.Q2. What industries do you serve?A2: We specialize in healthcare products, medical devices (ISO 13485 certified), automotive components (IATF 16949 certified), household electronics, portable electronic products, earphones, and precision industrial components.Q3. What certifications does Shun Hing hold?A3: We are certified to ISO 9001:2015, IATF 16949:2016, and ISO 13485:2016 standards, ensuring the highest quality for automotive, medical, and general manufacturing applications.Tooling & PrecisionQ4. What is your tooling precision capability?A4: Our tooling division achieves 0.01mm accuracy using five-axis CNC machining centers and Moore Jig Grinding Machines with 2μm precision. We use the EROWA positioning system ensuring tolerances no greater than 2μm between jig and machine interfaces.Q5. How long is the tooling development time?A5: Tooling development typically takes 4-8 weeks depending on complexity. Simple molds: 4-5 weeks, complex multi-cavity molds: 6-8 weeks. We provide regular progress updates throughout the development process.Q6. What is your mold life expectancy and warranty?A6: Our precision molds are designed for extended life cycles. Standard warranty is 500,000 shots for production molds. We provide comprehensive maintenance support and can extend mold life through our professional maintenance services.Production & QualityQ7. What is your production capacity?A7: We can produce up to 80 molds per month and more than 10 millions plastic part subject to the size of the produce. We also operate 5 assembly lines with 120 skilled workers, producing an average of 150,000 products per month. Q8. How do you ensure consistent quality?A8: We use Full Automatic CMM measurement systems, RFID tracking throughout production, and all servo motor injection machines for stable quality. Over 99% of our injection machines are imported from Japan, achieving 0.01mm stroke accuracy.Q9. What is your production leading time?A9: Standard production lead time is 2-3 weeks for injection molded parts after tooling completion, and 3-4 weeks for complete assembly projects. Rush orders can be accommodated with 1-2 week delivery upon request.Business Terms & LogisticsQ10. What are your trade terms?A10: Ex-works Dongguan, FOB Shenzhen, FOB Hong Kong. We can accommodate various shipping arrangements based on customer requirements.Q11. What are your payment terms?A11: T/T or L/C at sight. For tooling: 50% deposit upon order confirmation, 30% at first trial, 20% upon approval. For production: 30% deposit to start production, 70% balance before shipment.Q12. What documents do you provide for shipment?A12: Commercial Invoice, Packing List, Certificate of Origin, Quality Inspection Report, and any specific certificates required for your industry (medical device certificates, automotive compliance documents, etc.).Project Management & SupportQ13. Do you provide design and engineering support?A13: Yes, we have over 100 engineering and technical personnel providing comprehensive ME design, DFM optimization, prototyping services, and design for manufacturing consultation from concept to production.Q14. Can you handle complete turnkey projects?A14: Absolutely. We provide one-stop solutions including product design, prototyping, tooling, injection molding, surface treatment, assembly, and supply chain management for complementary components like metal parts, adhesives, and PCBA.Q15. What project management support do you offer?A15: We assign dedicated project managers who coordinate all aspects from initial design through final delivery, providing regular updates, managing timelines, and ensuring quality standards throughout the project lifecycle. However, please keep in mind that we can only provide Mechanical Engineering support in house, while we can assist and coordinate for you on other areas. Technical CapabilitiesQ16. What materials can you work with?A16: We work with a wide range of plastics including ABS, PC, PA, POM, TPU, as well as engineering plastic, such as PESU, COC, PEEK, PCTG and medical-grade materials. We can recommend optimal materials based on your application requirements.Q17. What surface treatments do you offer?A17: We provide spray painting, screen printing, In-Mold Labeling (IML), texture finishing, and various cosmetic treatments. Our IML department specializes in high-quality decorative and functional surface applications.Q18. Do you offer prototyping services?A18: Yes, we provide rapid prototyping using 3D printing, CNC prototype and rapid tooling techniques. This allows for design validation and testing before committing to production tooling, saving time and costs.Quality & ComplianceQ19. How do you handle quality issues or defects?A19: We maintain comprehensive quality records through our system. In the rare event of quality issues, we investigate root causes, implement corrective actions, and provide replacement parts or products as needed.Q20. Can you provide material certificates and test reports?**A20: Yes, we provide complete material traceability, test reports, and certificates of compliance for all materials used. For medical and automotive applications, we maintain full documentation per industry requirements.---Order Requirements & FlexibilityQ21. What is your minimum order quantity (MOQ)? A21: For plastic injection molding, we can accommodate orders as low as 100-200 pieces, with setup costs distributed equally across each part. For assembly products, we prefer a minimum of 3,000 pieces to ensure cost efficiency and optimal production scheduling.Q22. Do you offer samples, and what is the cost? A22: As we specialize in custom, non-standard parts, we cannot provide exact samples from existing inventory. However, we offer prototype development services at reasonable costs, allowing you to validate design and functionality before committing to production tooling.Q23. What geographic regions do you ship to? A23: We ship worldwide to all international destinations. Our experienced logistics team can arrange shipping to any global location with appropriate documentation and compliance requirements.Q24. Do you have any exclusivity or confidentiality agreements? A24: Yes, we can sign Non-Disclosure Agreements (NDAs) and confidentiality agreements with all clients to protect your intellectual property and proprietary designs. We understand the importance of maintaining strict confidentiality in competitive markets.Q25. What is your capacity for handling rush orders? A25: We accommodate rush orders whenever possible and typically do not charge additional fees, though this is subject to current production schedules and specific project requirements. We'll work with you to find the best solution for urgent delivery needs.Q26. Do you offer any post-delivery support or maintenance services? A26: Yes, we maintain comprehensive records of all projects and can provide detailed historical information and ongoing support. Our team can assist with troubleshooting, maintenance recommendations, and future modifications based on your production history with us.Q27. Can you handle regulatory approvals for medical or automotive applications? A27: Yes, we can provide support for regulatory approvals based on client needs. With our ISO 13485 and IATF 16949 certifications, we understand the documentation and compliance requirements for medical and automotive applications and can assist with necessary submissions.Q28. What is your policy on design changes during production? A28: Design changes are evaluated based on the production phase and associated costs. We provide detailed quotes for any requested modifications, considering the impact on tooling, production schedules, and material requirements to ensure transparent pricing.Q29. Do you offer any financing or payment plan options for large tooling investments? A29: Payment arrangements for large tooling investments are subject to project size and can be negotiated on a case-by-case basis. We're flexible in working with clients to structure payment terms that support their cash flow requirements while ensuring project success.Q30. What happens if there are delays due to material shortages or other external factors? A30: We communicate any potential delays to clients as soon as possible and proactively provide alternative material suggestions when shortages occur. Our experienced team works to minimize disruptions and find suitable solutions to keep projects on track. 

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