Medical Manufacturing

Many of Coi Rubber Products are  non-latex medical grade and are used as components in medical devices. We currently sell medical rubber products to virtually all major medical manufacturers. We provide component products that are manufactured to our customers’ unique specifications through print specific and governed manufactured processes and facilities to yield the highest of quality grade products. We can also manufacture finished non-latex medical rubber products as private label brands.   Our specialty is working with your design engineers in the early design stages of a medical device, as we can provide custom compounding services to create a custom rubber product suitable for your device.

Capabilities

  • Medical plastics manufacturing:
    • Injection moulding
    • Blow moulding
    • Extrusion
    • Insert moulding
  • Clean room facilities (100,000)
  • Sterilization
  • Tooling
  • Product design
  • Supply chain
  • Coatings (Hydrophilic & Antimicrobial)
  • All types of assembly operations

Your partner supplier

  • Components
  • Coatings
  • Materials

Facilities

  • Research & Development – Shanghai, China
  • Songjiang facility
  • Kunshan facility
  • Anhui facility
  • Headquarters – City of Industry, CA

Sterilization

  • EO In-house
  • Gamma (local)

Robust Quality Assurance Systems

  • Provide consistent and repeatable products
  • Validated processes
  • Qualification procedures (IQ, OQ, PQ)
  • Capabilitiy studies
  • Production control plans

Worldwide compliance certifications

  • cGMP (Current Good Manufacturing Practice)
  • ISO13485; ISO11135
  • FDA Audited and Registered
  • QSR (Quality System Regulation 21 CFR Part 820)
  • CE-Marks

Audits

  • All Coi Rubber customers conduct annual compliance audits, ensuring Coi Rubber manufactured products are in compliance.
  • Coi conducts key supplier audits on a regular basis.
  • QSR compliance is part of the Coi culture. Additionally, we utilize clear root cause analysis to continusously improve our overall performance.
  • TUV Notification Body

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