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Medical Device Contract Manufacturing & Assembly

Medical Device Contract Manufacturing & Assembly

Bringing a medical device to market requires good design along with precision, compliance, and the ability to scale without compromising quality. That's why so many OEMs turn to contract manufacturing partners to help manage complex assemblies, navigate regulatory requirements, and support the full product lifecycle.

GMI Solutions works with medical device manufacturers to provide outsourced assembly, integration, and Design for Manufacturability (DfM) services. With experience across a range of healthcare contract manufacturing applications, we help teams streamline production, reduce risks, and improve reliability from initial build to final delivery.

The sections below outline how GMI Solutions supports OEMs at every stage of development and production.

Solving Complex Manufacturing Challenges for Medical Device OEMs

Medical device OEM manufacturers face high-stakes challenges, including stringent regulatory environments and intense pressure for defect-free products. Speed to market and continuous product improvement are essential, but they can also be challenging to achieve without the right partner.

By embedding quality, compliance, and efficiency into every step, we help reduce the burden on your internal teams while maintaining the total integrity of the product. Our world-class medical device assembly and manufacturing capabilities are designed to scale easily with your production needs and align with your long-term roadmap.

GMI Solutions addresses these issues head-on through:

  • Expert outsourced assembly and integration. We tailor our OEM medical solutions to meet the specific needs of the healthcare and life sciences industries. This allows all of GMI's OEM customers to leverage the benefits of our high quality, extremely consistent product flow.
  • Design for Manufacturability (DfM) support. With DfM, we can boost efficiency without compromising innovation. DfM activities at all levels of the organization result in higher quality at a more competitive price. 

Comprehensive Medical Device Engineering & Manufacturing Services

We offer end-to-end services to support your product from the prototypes validation to the end-of-life stage:

  • Full product lifecycle support. We assist from launch to obsolescence with services such as sustaining engineering, end-of-life support, and out-of-warranty repairs.
  • Outsourced assembly & integration. Our capabilities include custom electro-mechanical assembly, application-level testing, embedded computing integration, full capital equipment builds, subassemblies, and mobile medical platforms.
  • Engineering services. These services include Design for Manufacturability (DfM), Design for Assembly (DfA), rapid prototype management, iterative development, and functional and safety testing at the application level.
  • Supply chain management. We handle sourcing, inventory, vendor coordination, and logistics, with the option to integrate client-approved suppliers for continuity and cost control. With greater supply chain control, OEMs gain flexibility and resilience in even the most volatile markets.
  • Quality & regulatory compliance management. Our facility is FDA registered, ISO 13485 certified, equipped with a Class 10,000 Clean Room, and able to perform 240V system testing. We also handle DHR creation, revision control, and certifications, including UL, CE, ETL, and China CCC.
Case Study: Rescuing Production of a Critical Medical Device Keyboard

Case Study: Rescuing Production of a Critical Medical Device Keyboard

Discover how GMI Solutions rescued a critical medical device keyboard project, virtually eliminating scrap and dramatically improving field reliability. Quality you can trust, delivered on time.

Read the Full Case Study

Why Leading OEMs Choose GMI Solutions for Medical Device Production

Our customers choose us not only for what we do, but for how we do it. Here are some of the key reasons to choose GMI Solutions for your medical device assembly and production:

Four Decades of Medical Expertise

Four decades of medical expertise.

We have over 40 years of medical device contract manufacturing experience, with special focus on regulated, complex environments. Our expertise spans imaging systems, treatment systems, patient monitoring, robotic surgical equipment and other critical care technologies.

Low-To-Medium Volume, High-Mix Specialization

Low-to-medium volume, high-mix specialization.

We're optimized for highly engineered products instead of mass production. This gives us flexibility that supports pilot runs, legacy products, and next-generation designs with equal precision.

Proactive Dfm & Engineering Support

Proactive DfM & engineering support.

From concept to production, our engineering experts continually refine processes to accelerate launches and reduce costs. We collaborate closely with your design team to improve manufacturability without sacrificing function.

Global Reach with Critical Certifications

Global reach with critical certifications.

Our facilities in North America and Asia are certified per ISO 13485 and China CCC standards. Our global footprint enables OEMs to scale efficiently while meeting regional market requirements.

Dedicated & Nimble Team

Dedicated & nimble team.

Our experts are responsive, reliable, and ready to act. We're structured to make quick decisions and adjust production schedules as needs change.

Commitment to Long-term Partnership

Commitment to long-term partnership.

We invest in each customer relationship with the goal of becoming an extension of your internal team and building sustained success.

Problem-Solving Focus

Problem-solving focus.

Whether it's a complex electro-mechanical system or an embedded computing integration, we lean in to solve even the toughest challenges. Our track record includes resolving late-stage production issues, optimizing legacy designs, and supporting rapid design transfers.


Examples of Our Work: Medical Device Contract Manufacturing

From imaging systems to patient interfaces, the projects we have completed reflect the versatility of our production capabilities and the breadth of our experience in supporting medical OEMs. Here's a glimpse of what we help bring to life:

  • Medical imaging and treatment control cabinet
  • Robotic surgery carts and cabinets
  • HIFU (high-intensity focused ultrasound)
  • Oncology system assemblies
  • Patient input devices
  • Exoskeleton systems to help patients recover
  • RF generation system
  • Connected health kiosk
>> Ready for a deeper dive? Find more information on these medical devices and other OEM products we build

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Contact GMI Solutions to Start Your Medical Device Project Today


Whether you need low-volume, high-mix production or specialized assembly, we're ready to support with OEM services for the medical sector. GMI Solutions can help your medical device reach the market faster, more efficiently, and with complete compliance.

Simply fill out the form below, and a member of our team will be in touch with you.