Medical Device & Healthcare Plastic Component Manufacturing
Our Southern California facility is equipped with advanced technology, including the Brown and Sharpe CMM for precision measurements to ±0.0001 inches, enabling us to meet the tight tolerances essential for healthcare plastic components. As experienced medical injection molding companies, our capabilities extend from prototype development through high-volume production, supported by comprehensive documentation systems that provide complete traceability for every component we manufacture.
With over 50 years of manufacturing experience, Norco Plastics delivers the stability and expertise that medical device manufacturers require. Our team understands the critical nature of healthcare applications, implementing specialized protocols for material handling, contamination prevention, and consistent production that medical and healthcare manufacturers can rely on for their most important components.
±0.0001"
PRECISION MEASUREMENT
FOR MEDICAL COMPONENTS
100%
BATCH TRACEABILITY
FOR REGULATORY COMPLIANCE
Medical-Grade
SPECIALIZED MATERIALS
FOR HEALTHCARE APPLICATIONS
Meeting the Exacting Standards of Medical Device Manufacturing
Medical device manufacturing presents unique challenges that demand specialized expertise and precision manufacturing capabilities. At Norco Plastics, we understand the critical nature of healthcare applications and have developed comprehensive solutions that address the complex requirements of the medical industry. Our approach combines advanced technology with rigorous quality control systems to deliver components that meet the most demanding specifications.
Regulatory Compliance & Documentation
Medical devices require comprehensive documentation and adherence to stringent regulatory standards. Our fully traceable production processes include detailed documentation for every component, supporting your regulatory submissions and audit requirements.
Strict Tolerance Requirements
Medical components often require precision measurements to ensure proper fit and function. Our Brown and Sharpe CMM technology delivers accuracy to ±0.0001 inches, maintaining tight tolerances that are critical for medical applications.
Material Biocompatibility
Healthcare applications require materials that are safe for human contact and meet specific performance characteristics. We can recommend USP Class VI polymers, medical-grade polycarbonates, and antimicrobial compounds that meet healthcare industry standards. While we provide material guidance, customers make final selection decisions.
Consistency & Traceability Demands
Medical manufacturing requires complete traceability from raw material to finished component. Our comprehensive batch tracking system maintains detailed records of every production parameter, material lot, and quality verification step. This enables rapid response to any quality concerns and supports complete documentation for regulatory compliance. Every component we manufacture is fully traceable throughout its lifecycle, providing the documentation trail essential for medical device manufacturers.
Non-Invasive Medical Components and Healthcare Products
Norco Plastics specializes in precision manufacturing of non-invasive medical components that maintain the highest standards of quality and consistency. Our injection molding capabilities are perfectly suited for the exacting requirements of healthcare applications, delivering components with exceptional dimensional accuracy, clean finishes, and reliable performance.
Key Medical & Healthcare Applications
Diagnostic Equipment Components
Precision housings, interfaces, and structural components for diagnostic instruments requiring exceptional dimensional stability and clean finishes.
Medical Sample Trays and Containers
Custom-designed storage solutions for laboratories and healthcare facilities, with precise compartment sizing and sterile surface finishes.
Healthcare Facility Equipment Parts
Durable components for hospital and clinical equipment with antimicrobial materials and ergonomic designs for healthcare environments.
Medical Device Housings and Enclosures
Protective enclosures for sensitive electronic equipment with precise tolerance control and specialized medical-grade materials.
Handheld Device Components
Ergonomic cases, buttons, and interfaces for portable medical technology with precise fit and durability for daily clinical use.
Material Options for Medical-Grade Components
For medical and healthcare applications, we can recommend specialized materials based on their safety, performance, and compliance with industry regulations. We can advise on a comprehensive range of medical-grade polymers that offer the specific properties required for healthcare environments, from biocompatibility to chemical resistance.
All materials are fully documented with material certifications, lot traceability, and quality verification data. This documentation supports regulatory submissions and provides complete transparency throughout the production process. While we provide comprehensive material guidance based on application requirements, customers make the final material selection decisions, particularly for applications with potential liability concerns.
Medical-Grade Materials We Work With
- USP Class VI certified medical polymers
- Medical-grade polycarbonate (PC) with exceptional clarity
- Antimicrobial compounds for healthcare environments
- Chemical-resistant materials for laboratory applications
- High-performance acrylics (PMMA) for optical clarity
- Medical-grade ABS for durable structural components
- Thermoplastic elastomers (TPE) for flexible applications
- Complete material traceability documentation
Material Recommendation Considerations
- Biocompatibility requirements
- Chemical resistance needs
- Sterilization compatibility
- Clarity and optical properties
- Dimensional stability
- Mechanical properties
- Regulatory compliance
- End-use environment
Quality Control for Medical Manufacturing
Precision Measurement & Verification for Healthcare Components
The medical industry demands exceptional quality control systems to ensure component reliability and consistency. Our facility features comprehensive quality verification technology, including the Brown and Sharpe CMM (Coordinate Measuring Machine) capable of dimensional verification to ±0.0001 inches. This precision is essential for medical components where tight tolerances directly impact functionality.
We implement Statistical Process Control (SPC) methodologies specifically tailored for medical manufacturing, with in-process monitoring and comprehensive data collection that verifies consistency across production runs. Our quality systems include specialized protocols for cleanliness verification, surface inspection, and contamination prevention that meet healthcare industry standards.
Documentation is a critical component of our medical quality control system, with detailed records maintained for every production batch. This includes material certifications, process parameters, inspection results, and traceability data that supports regulatory compliance and provides complete transparency throughout the manufacturing process. Our measurement capabilities ensure that every medical component meets exact dimensional specifications, with verification reports available for regulatory submissions.
Clean Manufacturing Practices for Medical Components
Medical device manufacturing requires specialized environments and handling protocols to ensure product integrity and performance. Our facility implements comprehensive cleanliness standards and controlled handling procedures specifically designed for healthcare components, maintaining the necessary conditions for medical-grade production.
Clean Manufacturing Practices
Our manufacturing environment incorporates specialized cleanliness protocols, including controlled access points, regular surface cleaning, and air filtration systems that minimize particulate contamination. Equipment is regularly sanitized according to documented procedures specific to medical production.
Material Handling Procedures
Our material handling systems maintain separation between raw materials and finished components to prevent cross-contamination. Materials are stored in controlled environments with dedicated handling equipment and documented transfer procedures throughout the production process.
Employee Training for Medical Standards
Our production team receives specialized training for medical component manufacturing, with documented qualification processes and regular refresher courses. This training includes contamination prevention, quality verification procedures, and regulatory awareness specific to healthcare applications.
Quality Assurance Throughout Production
Our quality assurance system for medical components includes verification checkpoints at each critical stage of production. From material reception through final inspection, dedicated quality technicians perform documented verification procedures using calibrated measurement equipment. Statistical process control methodologies monitor key parameters in real-time, enabling immediate intervention if process drift is detected. This comprehensive approach ensures consistent quality and complete documentation for each production batch.
Common Questions About Medical Component Manufacturing
What types of non-invasive medical components does Norco manufacture?
Norco Plastics specializes in manufacturing a wide range of non-invasive medical and healthcare components including diagnostic equipment housings, medical sample trays and containers, healthcare facility equipment parts, medical device enclosures, and handheld device components. Our injection molding capabilities are particularly well-suited for components requiring precision tolerances, clean finishes, and consistent quality across high-volume production runs.
How does Norco ensure cleanliness in medical component production?
Our facility implements specialized cleanliness protocols for medical component production, including controlled access manufacturing areas, HEPA filtration systems, and regular surface cleaning procedures. Materials and components are handled with designated equipment to prevent cross-contamination, and our production team follows documented procedures for maintaining clean conditions throughout the manufacturing process. Additionally, finished components undergo inspection for particulate contamination as part of our comprehensive quality verification system.
What material options are available for medical device applications?
We can advise on a comprehensive range of medical-grade materials, including USP Class VI certified polymers, medical-grade polycarbonate with exceptional clarity, antimicrobial compounds for healthcare environments, chemical-resistant materials for laboratory applications, high-performance acrylics (PMMA) for optical clarity, medical-grade ABS for durable structural components, and thermoplastic elastomers (TPE) for flexible applications. Our material recommendation process considers specific application requirements, including biocompatibility, chemical resistance, sterilization methods, and mechanical properties. While we provide comprehensive guidance on material options, customers make the final material selection decisions, particularly for applications with potential liability concerns.
What quality control measures are in place for healthcare products?
Our quality control system for healthcare products includes precision measurement with our Brown and Sharpe CMM (±0.0001" accuracy), statistical process control (SPC) for monitoring critical parameters, comprehensive in-process inspections at key production stages, and final verification of all critical dimensions and visual characteristics. Every production batch undergoes documented quality verification with traceability to materials, process parameters, and inspection results. Our quality technicians are specifically trained in medical component verification, ensuring consistent adherence to the rigorous standards required for healthcare applications.
Can Norco provide the documentation required for medical device manufacturing?
Yes, we provide comprehensive documentation for medical components that supports regulatory compliance and quality verification. This includes material certifications with lot traceability, first article inspection reports with detailed dimensional verification, process validation documentation, statistical process control data, and batch production records. Our documentation system is designed to meet the requirements of medical device manufacturers, providing the verification and traceability data needed for regulatory submissions and quality assurance. We can work with you to develop custom documentation packages that address your specific regulatory and quality requirements.
Need Precision Medical Components with Complete Traceability?
Contact us about your medical or healthcare application. Our facility specializes in precision manufacturing for non-invasive medical components with the quality control systems and documentation that medical device manufacturers require. From diagnostic equipment components to laboratory sample containers, we deliver exceptional quality with complete traceability and consistent performance across production runs.
(909) 393-4000 
