Medical Devices

Medical and laboratory instrument manufacturers face unique challenges in producing high-quality enclosures and functional components. Our comprehensive manufacturing capabilities, including Reaction Injection Molding (RIM), precision CNC machining, and advanced reverse engineering, deliver precise, durable solutions that meet rigorous industry standards.

Engineering Excellence for Medical Applications

Our ISO 9001:2015 certified facility specializes in manufacturing critical medical device components where precision, reliability, and quality documentation are paramount. Through our engineering-led approach, we help medical device manufacturers overcome complex challenges in instrument design and production. Our expertise extends from designing and producing instrument enclosures with complex geometries to developing housings that protect sensitive electronic components while maintaining biocompatibility. We focus on creating functional components that enhance device performance and durability, all while ensuring strict compliance with industry regulations and quality standards.

Reaction Injection Molding (RIM)

Our RIM process excels at producing medical device enclosures and components that demand the highest levels of precision and performance. We achieve exceptional dimensional stability for accurate component fitting while ensuring excellent chemical resistance to withstand rigorous sterilization processes. Our advanced processes deliver superior surface finish quality suitable for clean room environments and the ability to produce complex geometries with varying wall thicknesses. We incorporate EMI/RFI shielding capabilities to protect sensitive electronics when required.

Precision CNC Machining

Our precision CNC machining services complement our RIM capabilities, enabling us to produce tight tolerance components for critical medical applications. This technology allows us to create custom fixtures and assembly tools, support prototype development and testing, and perform necessary secondary operations and finishing work. The integration of these capabilities ensures complete control over component quality and precision.

Reverse Engineering Solutions

We help medical device manufacturers modernize legacy components through advanced reverse engineering capabilities while maintaining essential form and function. Our comprehensive process creates detailed documentation for regulatory compliance, optimizes existing designs for improved performance, and develops reliable replacement parts for obsolete equipment. This expertise proves particularly valuable when updating older medical devices or improving existing designs.

Quality Assurance and Documentation

The critical nature of medical device manufacturing demands exceptional attention to quality control and documentation. Our ISO 9001:2015 certified manufacturing processes ensure complete lot traceability and thorough documentation. We provide comprehensive First Article Inspection Reports (FAIR), material certification and compliance documentation, and implement detailed quality control procedures and testing protocols throughout the manufacturing process.

Material Science Expertise

Our deep understanding of material science ensures optimal performance for medical applications. We work extensively with Poly-DCPD formulations that offer enhanced chemical resistance and biocompatibility for medical environments. Our material selections include options for fire-retardant compositions, anti-microbial properties, and sterilization-validated materials, ensuring that each component meets specific application requirements while maintaining compliance with medical industry standards.

Partnership Approach

Our relationship with medical device manufacturers extends throughout the product lifecycle, beginning with early design collaboration to ensure optimal manufacturability. We provide extensive material selection guidance, support prototype development and testing, develop production scaling strategies, and offer ongoing technical support and documentation. This comprehensive approach ensures successful outcomes at every stage of product development and manufacturing.

Proven Track Record

Our experience in medical device manufacturing encompasses a wide range of successful applications. We've developed and manufactured laboratory diagnostic equipment enclosures, medical imaging system components, clinical analyzer housings, surgical equipment enclosures, and diagnostic instrument panels. Each project demonstrates our commitment to precision, quality, and reliability in medical device manufacturing.

Getting Started

Partnering with us begins with an initial consultation to understand your requirements, followed by a thorough technical review and material selection process. We then move through design optimization for manufacturing, prototyping, and validation, and finally, to production implementation with full quality documentation. 

Contact our engineering team today to discuss your medical device manufacturing requirements and discover how our comprehensive capabilities can support your product development goals.