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.
Compliance and timeline risks
Check out the Donatelle guide to learn more about “How to Avoid Compliance & Timeline Risks”
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.