1-800-211-9897 info@moldeddevices.com

Clean Room Assembly

In order to properly produce a number of medical-grade products, medical device companies seek out both clean room manufacturing and assembly services. These clean room manufacturing and assembly environments meet a strict standard for sanitary production, according to the number of particles (sized 0.5µm or larger) in one cubic foot of air. At MDI, we offer clean room assembly for various medical device companies, with adherence to the ISO 13485 standard for organizations involved in the design, production, installation and servicing of medical devices. Depending on the unique needs of your product, we can achieve ISO 1-9 classifications, offering clean room assembly services rated between 100 particles per square foot and 100,000 particles per square foot. Our services relating to clean room manufacturing and assembly include:

  • Molding
  • Extrusion (single, multi, and co-extrusion)
  • Bonding (UV and Solvent)
  • Decorating
  • Flaring
  • Tipping
  • Packaging (Pouch and Tray)
  • Force Testing (Pull force, burst, and torque)
  • IQ/OQ/PQ Validations

MDI partners with several trusted outside vendors who provide us with metal components like hypotubes, needles, trocar shafts, machined components, and tooling services. We can produce products like medical balloons, catheters, cannulas, tubing, and a variety of unique single-use medical devices – at virtually any production scale. Combining our outside resources for medical-grade components and parts with our in-house capabilities allows us to truly provide comprehensive medical device production services. From the initial prototype design, to final product delivery – our team at MDI has years of experience bringing complex medical components and devices to market, with sophisticated clean room assembly services. Call us today at 1-800-211-9897, or use our contact page and we will respond within one business day to begin helping you with your project needs.