Manufacturing

Our comprehensive manufacturing, packaging, and quality assurance services are based in the U.S.

Take your medical device from concept to completion with our state-of-the-art facilities and proven expertise, all with a single manufacturer.

Medisurge’s Manufacturing Capabilities

Medisurge specializes in producing high-mix, low-volume medical devices in sterile environments. Our sophisticated production facilities are equipped to turn out virtually any design. We can also advise you on adapting your product to our production processes to reduce the time and cost to make each unit while preserving quality and functionality.

As a U.S.-based manufacturer, we offer numerous advantages to OEMs searching for a reliable production partner. Our highly-trained workforce ensures clear, rapid communication, allowing us to adapt to your unique demands. We also have a protected supply chain, allowing us to avoid disruptions from overseas suppliers and distributors.

Technicians in a cleanroom assembling the Blowmister device, focusing on meticulous quality control for surgical equipment

Inside Our Manufacturing Process

We utilize lean manufacturing techniques to reduce waste and improve production efficiencies at each level of the production process. Our vertical approach to production, packaging, and distribution gives us a high level of control over the design of your product. This allows us to efficiently conduct quality control, ensuring that your final product meets your specifications.

Through our commitment to quality, we’re constantly improving our production processes and manufacturing facilities to drive efficiency while maintaining quality.

We’re ready to serve you if you want a manufacturer that delivers consistent, high-quality products. In addition to our manufacturing services, we offer seamless market entry support and help you navigate medical regulations effectively.

Medisurge assembler using a UV curing device to solidify UV glue in a Class 7 cleanroom, ensuring strong bonds in medical device assembly with Green Spot and QX4 systems

Certified Class 7 Cleanroom

Our certified Class 7 cleanroom can control contamination and particulate matter for products such as medical devices. Our certified class 8 incoming inspection cleanroom further demonstrates our commitment to producing quality, safe, effective products.

In our Class 7 cleanroom, we undertake low-volume, high-mix assemblies. Within this environment, we can produce the following product market segments:

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Cardiovascular surgery single-use disposable devices

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Blood management

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Temperature management

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Blood infusion devices

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Extracorporeal cannulae

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Wound care

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Cryostorage and disposables for cell and gene therapy

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Disposables supporting electrosurgical systems and thermal ablation

Our clients receive the benefits of managed sterilization in a U.S.-based manufacturing facility. Our ultrasonic cleaning and passivation equipment creates a medically sterile environment during production, while our sterile barrier packaging protects your products from contamination.

CNC Metal Machining

With state-of-the-art CNC milling, CNC lathe, and Swiss Lathe capabilities, we redefine excellence in crafting medical devices. Our commitment to precision engineering ensures impeccable accuracy, meeting the strictest industry standards while optimizing production time.

Equipment List

We use state-of-the-art equipment in our facility to manufacture high-precision products to exact specifications. Our expertise allows us to provide input into your design to produce your request at a high volume for the lowest price without sacrificing quality or safety.

We use the following equipment in our production processes:

  1. 3-axis vertical CNC Mill (3)
  2. CNC Lathe (1)
  3. Swiss Lathe (1)
  4. Suture Guide Press
  5. Ultrasonic Welder
  6. Collaborative Robot
  7. Tray sealers (2)
  8. Pouch sealers (9)
  9. UV Gluing dispensers/curing lights
  10. Solvent bonding dispenser
  11. Tube bender
Vented antegrade cannula for fluid management in surgical procedures, designed for accurate venting and flow control during cardiovascular surgery
Large rigid cardiac sucker used in cardiovascular surgeries for precise suction, featuring a stainless steel tube and ergonomic blue handle.
Clear plastic medical connector component used for secure attachment in fluid management systems, ensuring reliable connection during procedures.
Straight antegrade cannula used in cardiovascular procedures, designed for controlled fluid delivery with a clear and blue-tipped design.
Multiple perfusion set with clear tubing and red and blue clamps, designed for precise fluid management in cardiovascular procedures.
Manual inflating retrograde cannula for controlled blood flow in cardiovascular surgery, featuring syringe and tubing components.

Products

At Medisurge, we make essential medical devices that support various critical procedures. Our advanced Class 7 cleanroom ensures the highest standards for products like cardiovascular surgery disposables, blood management tools, temperature management devices, and more. Our U.S.-based facility manages sterilization, uses ultrasonic cleaning, and provides sterile packaging to keep products safe and effective. Our CNC metal machining division, equipped with top-tier CNC milling, lathe, and Swiss lathe technology, produces high-precision knee and hip implants. We focus on quality and innovation to give healthcare professionals reliable tools that make a difference in patient care.

Certifications

We produce our devices and packaging in facilities with ISO 11607 compliance, allowing us to serve your customer base. We also offer ISO 11607 compliance consultation services to advise you on bringing your facility to this production standard.

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

Get a Quote

Contact us today to get a quote for manufacturing your medical device. Our facilities are all in the United States and can handle small-batch and large-scale production. We can also assist you with distribution, including to the U.S. government, allowing you to fulfill all your design, production, and distribution needs under one roof.

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Contact

Medisurge

2140 Oak Industrial Dr NE
Grand Rapids, MI 49505

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