Contract Manufacturing 

A VALUE ADDED SERVICE

Picocyl provides Contract Manufacturing for Medical Device Class II and III. 

Manufacturing excellence is at the core of Picocyl. Our manufacturing facility and quality system were meticulously designed from the ground up with a focus on the exacting standards of medical device manufacturing. From our ISO 13485:2016 certified quality system, to our Class 8 clean room, we have created a culture of quality that extends to every person we hire and process we create. This started with our world class automated Pico-cylinder manufacturing lines that have produced millions of leak-free Pico-cylinders. The same attention to detail has continued with every manufacturing line that we have created or transferred to our facility, always maintaining the highest standards of reliability in the products we produce.  Picocyl provides turn-key solutions for manufacturing sub-assemblies through to fully assembled and packaged devices.

Subassemblies

  • Allow us the opportunity to assemble our Pico-cylinders, Opener Pins, and Actuators into a sub-assembly for your device.
  • We can provided custom packaging to ensure that the subassemblies arrive safely wherever they are assembled into your final device.

    Product line transfer for existing device

    • Transfer your existing supply chain and manufacturing equipment to our US manufacturing facility in Golden, Colorado.
    • ISO Class 8 cleanroom.
    • Dedicated project manager to oversee transfer.
    • Process validation / revalidation expertise.
    • Import of work instructions, BOM, Drawings, and vendors into quality system
    • Highly trained team to ensure fast and reliable validation of manufacturing equipment.

      New Product Introduction

      • Trust our team of design, manufacturing, and quality engineers, and supply chain experts to design, build, and scale a manufacturing line that matches the needs of your timeline and forecast.
      • Quick-turn, low volume fixture design and fabrication for pilot lines
      • World Class automation assembly equipment for high volume and high effectiveness production, partnerships with automation experts.

        Standard Services

        • FDA and notified body audit compliance
        • Design for manufacturability and assembly assessments
        • Design for Six Sigma
        • Supply chain management
        • Manual and automated receiving and in process inspections
        • Process flow mapping and line layouts
        • Training and training management
        • Current good manufacturing practices (GMP)
        • Continuous Improvement
        • Partnerships
          • Injection molding (local and overseas)
          • Deep drawing
          • Stamping
          • Automation
        • Component and Device History Record
        • Material Inventory management
        • Logistics
        • Calibration
        • Labeling