Medical devices and components for diagnostics
Our team of engineers, designers, machinists and toolmakers will work closely with your team to scientifically determine the most reliable, accurate and cost-effective parameters for your product. Plus, our manufacturing operates on a continuous basis to meet supply chain and forecast needs.
As a leading single contract manufacturing source, from design for manufacturability through delivery, we offer:
- 45+ molding machines (5- to 300-ton capacity) to precisely produce molded components – including micro-, insert- and over-molded.
- 40+ Swiss CNC turning centers and two 5-axis bar-fed machining centers for precision machined components.
- Expertise and experience across all engineered and implantable-grade plastics (including polymers, silicones and PEEK), metals (including stainless steel, titanium and MP35N) and exotic materials.
- Specially designed systems and absolute quality standards to achieve extremely tight tolerances.
Plus, we’ve set the standard of excellence for quality systems – our facility is FDA registered and inspected with no Form 483 observations. From design through shipment, our quality assurance processes utilize ISO-9001 and ISO-13485 certified systems.
We’ve also earned – and maintain – an impeccable track record for regulatory compliance, meeting deadlines and on-time delivery.
7 Critical Factors for Predictable Quality in Medical Device Manufacturing
Get exactly the specialized support you need to bring your Class I, Class II and Class III diagnostic medical products to market with confidence. Our expertise includes:
- Microfluidics devices
- Point-of-care testing
- And more!
Our suite of integrated contract manufacturing services, enhanced by our SmartStack® and NeuroStack® technologies, provides a competitive advantage with customizable linear contact systems. Plus, our facility features controlled environments, ISO 7 (class 10,000) cleanrooms and cleanroom production cells with integrated vision systems capable of operating at ISO 5 (class 100) level. *Moldflow® is a registered trademark of Autodesk® Inc.