Medical devices and components for diagnostics

medical device product development process
With demand so high for diagnostics solutions, we understand speed to market is critical. Our highly qualified team – backed by 30-plus years producing hundreds of thousands of diagnostics medical devices and components – will help drive continuity, quality and efficiency into your program.

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.

Expert insights

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!
501 County Road E2 Extension
New Brighton, MN 55112
Phone: +1-651-633-4200
Fax: +1-651-633-5486