Manufacturing & Assembly

Precision Manufacturing for Complex Medical Devices.

At Medisurge, we specialize in high-mix, low-volume manufacturing tailored to the needs of OEMs and healthcare innovators. Our U.S.-based facility combines cutting-edge equipment, ISO-certified cleanrooms, and expert craftsmanship to take your medical device from concept to full-scale production.

What We Offer

Vertically Integrated Manufacturing Services

We provide seamless integration from machining to assembly, sterilization, packaging, and distribution—all under one roof. This gives you better quality control, faster turnaround times, and reduced risk throughout the production lifecycle.

Cleanroom Assembly & Environmental Control

  • Class 7 Cleanroom: Used for sterile device assembly
  • Class 8 Incoming Inspection Room
  • Lean manufacturing practices for optimized workflow

Device Types Produced:

  • Cardiovascular single-use devices
  • Blood management tools
  • Temperature management systems
  • Cryostorage disposables
  • Electrosurgical system disposables
  • Cell & gene therapy support items
  • Orthopedic and implant-related components
Technicians in a cleanroom assembling the Blowmister device, focusing on meticulous quality control for surgical equipment

Advanced Capabilities

CNC & Swiss Lathe Machining
Our in-house machining capabilities allow us to meet precise tolerances for components requiring advanced geometries or tight quality standards.

Equipment Includes:

  • (3) 3-axis vertical CNC mills
  • (1) CNC lathe
  • (1) Swiss lathe
  • Suture guide press
  • Ultrasonic welder
  • Tray and pouch sealers (11 total)
  • UV curing systems
  • Solvent bonding and tube bending stations
  • Collaborative robotic automation

Assembly Processes:

  • Soldering, sewing, bonding, and curing
  • Final good (FG) assembly and testing
  • Visual and dimensional quality inspection

Why Choose U.S.-Based Manufacturing?

  • Faster communication and better collaboration
  • Greater agility for custom or low-volume runs
  • Protected, resilient supply chain free from overseas disruptions
  • Full regulatory alignment with U.S. standards and agencies

“Our facility and people give you confidence that every part of your device is being built with care, clarity, and compliance.”

Integrated Sterilization & Packaging Support

In addition to in-house assembly, we offer:

  • EO sterilization cycle control
  • Ultrasonic cleaning and passivation
  • ISO 11607-compliant sterile barrier packaging

This eliminates the delays and complexity of coordinating with external sterilization vendors, enabling faster market readiness.

Medisurge staff assembling and packaging medical devices in a state-of-the-art Class 7 cleanroom, ensuring strict adherence to sterile production protocols

Get Started

Contact us today to get a quote for manufacturing your medical device. Whether you’re preparing a prototype or scaling production, Medisurge has the tools, people, and environment to get it done right.

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Contact

Medisurge

2140 Oak Industrial Dr NE
Grand Rapids, MI 49505

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