Custom Medical Device Design and Manufacturing

ISO 13485:2016 Certified Design & Manufacturing

FDA Registered Facility

Complete Fulfillment & Testing

    ControlTek has been designated a critical supplier of medical and military products by the Washington Military Department, Emergency Management Division (EMD). We plan to maintain production levels to support our customers throughout the COVID-19 crisis. 

    Medical Device Design and Manufacturing Experience

    • Electro-Therapeutic Devices
    • Laboratory Instrumentation
    • Pharmaceutical Cabinets
    • Surgical Equipment
    • Blood Analysis Devices
    • Blood Pressure Monitoring
    • Delivery Devices (Flow Meters, Mixed Device Delivery)
    • Magnetic Bone Growth
    • Patient Monitoring Equipment (Oxygen Monitors, Respiratory Monitoring)
    • Patient Testing Devices
    • Patient Diagnostics
    • Cancer Treatment Devices
    • Ovulation Monitoring
    • Medical Carts
    • Anesthesia Monitoring

    Why Choose ControlTek

    ControlTek’s quality system is certified to ISO 13485:2016 and medical device design and manufacturing services are completed at our FDA Registered facility in Vancouver, WA USA. We have years of experience navigating the highly regulated medical industry and the exacting requirements necessary for products to comply with FDA Good Manufacturing Practices for Medical Devices.

    Quality System Integration. At ControlTek, our rigorous processes are managed by a Quality System that can integrate seamlessly with your own. Take advantage of the systems we already have in place to meet tough medical requirements. That includes validation of in-house tools, processes, and even vendor and supply chain management and documentation.

    Test Expertise. Thorough testing is needed to ensure finished product works as intended. ControlTek's dedicated test engineers will work closely with you to create a custom testing plan to verify product meets your requirements and that every element of your design is fully functional before it ships. Early involvement during design can provide additional value, helping you minimize your risk and get your product to market faster.



    From Concept to Fulfillment

    ControlTek has the expertise and tools you need to bring your electronic medical devices to market successfully. 

    At every stage of your product's development, from design and PCBA to circuit assembly and testing, you'll find a partner that's dedicated to bringing your big ideas to life while protecting your important investments.

    Medical System Integration

    Many of our medical customers require fully integrated systems. Our box build and electro-mechanical assembly services are all completed in-house to meet the high level of quality our medical customers require. 

    We can even assist with shipping and packaging requirements and validation.

    Request a consultation with our team of experts today.

    Medical Device Engineering

    ControlTek's design engineering meets FDA requirements and supports 510k provisions.

    • Electronic Circuit Design
    • PCB Layout
    • Firmware Development
    • Microcontroller and Embedded Systems Design
    • Systems Design
    • Product Engineering Support

    Printed Circuit Board Assembly

    Take advantage of our high-speed tools and systems for fast, quality manufacturing. 

    • Three Full SMT Lines
    • Quick Change Out
    • Low Volume, High Mix Assembly
    • Single and Double-sided PCBs
    • Super Fine Pitch and 0201 Capabilities
    • BGA and Micro BGA Assembly
    • PCB Prototypes
    • Large Format Multi-Layer Assembly

    Medical Cable Assembly

    ControlTek designs and manufactures custom cables and cable systems that meet IPC/WHMA-A-620 standards.

    • Custom Cables and Cable Systems
    • IPC/WHMA-A-620 Certified Assembly
    • Fully Automated Assembly Available
    • RF Coaxial / Triaxial Cables
    • Wire Kits
    • Complex Wire Harnesses
    • RF Cable Testing

    Box Build Assembly / System Integration

    Electromechanical box build assembly and system integration services ensure medical devices are fully compliant right to the packaging.

    • Custom Box Builds
    • Systems Integration
    • Product & Environmental Testing
    • Assembly Instructions
    • In-House Production & Fulfillment