Contract manufacturing

medical device product development process

For your Class I, Class II and Class III medical devices and components, take advantage of our full range of contract manufacturing capabilities – all in one location – to drive continuity, quality and efficiency into your program.

Get exactly the level of support you need, from a single manufacturing process to a complete solution, for high- and low-volume needs. Manufacturing operates on a continuous basis to meet supply chain and forecast needs.

  • Our vertically integrated services span medical device design, development and prototyping through manufacturing, secondary operations, assembly, barcoding, packaging, labeling, sterilization management, process validation and delivery.
  • 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.
  • Our state-of-the-art facility features controlled environments and ISO 7 (class 10,000) certified cleanrooms, as well as cleanroom production cells with integrated vision systems that can operate at ISO 5 (class 100) level.

With our highly qualified, experienced team, you can rest assured each step on the way to market, knowing we adhere to the industry’s highest standards and best practices. Plus, we’ve earned – and maintain – an impeccable track record for regulatory compliance, meeting deadlines and on-time delivery.

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Specializing in medical device product development for:

  • Cardiac rhythm devices
  • Diagnostic devices
  • Drug delivery systems
  • Neuromodulation devices
  • Ophthalmic devices
  • Orthopedic devices
  • Surgical devices
  • Vascular devices
  • And more!

Bring your Class I, Class II and Class III medical device products to market with confidence. Contact us!

TUV SUD ISO 9001 logo
TUV SUD ISO 9001 logo
501 County Road E2 Extension
New Brighton, MN 55112
Phone: +1-651-633-4200
Fax: +1-651-633-5486