FDA-Compliant Box-Build Medical Device Manufacturer
As a trusted medical device manufacturer specializing in box-build contract manufacturing, we are here to support OEMs every step of the way, from initial concept, final production, warehousing, to distribution.
Your Trusted Medical Device Manufacturing Partner
At MFG One, we understand the passion and dedication that go into developing life-altering medical and healthcare products. Our mission is to bolster your medical design and device manufacturing process while you focus on other priorities of your business.
- Transparent Open Book Costing: Gain complete visibility into your manufacturing costs for better budget management.
- USA-Based Facility: Benefit from faster lead times and superior craftsmanship at our FDA-certified center.
- Certified in Quality and Compliance Standards: FDA Registration and ISO 13485 certifications support adherence to stringent medical device regulations.
- 100% Clean Audit Record and Zero Defects: With over seven years of continuous FDA-compliant operations and a 100% clean audit record, we make your product fully prepared for market entry.
Box Build Medical Device Manufacturing Services for Fully Market-Ready Products
As a trusted provider of manufacturing support services, we specialize in turnkey manufacturing and box build assembly for medical devices. From initial concept to final production, our expertise helps your medical equipment get to the market faster while satisfying the highest standards of quality and compliance.
How We Build Complete Medical Device Equipment from Start to Finish
As a full turnkey manufacturing provider, our box-build process integrates every step required to deliver FDA-approved medical device equipment
Applications We Support
We are a leading medical device manufacturer, providing turnkey manufacturing and box-build assembly for a range of equipment, such as advanced fluid warming systems for other medical companies. Here are a few examples of what we’ve built:
- ThermaCor® 1200 Rapid Infuser
- Temp 3® Fluid Warming System
- Temp 2® Fluid Warming System
- Temp 1® Fluid Warming System
- T Hold® 1000 Fluid Warming System
- Heat-Stack® Fluid Warming System
- 16N1® Fluid Warming System
- 8N1® Fluid Warming System
MFG One is a medical device manufacturer that supports the development of convective patient warming systems designed for superior patient care for systems similar to this:
- Cocoon™ Convective Patient Warming System
For new medical device product development, we utilize plastic injection molding and custom metal stamping to manufacture durable enclosures and housings for medical devices:
- Custom enclosures for patient monitoring systems
- Housings for diagnostic imaging equipment (portable ultrasound, etc.)
- Precision-machined components for surgical instruments
- Durable casings for infusion pumps and drug delivery devices
We support the medical device design and manufacturing of compact, durable portable and wearable medical devices using plastic injection molding and metal fabrication. Our capabilities include:
- Wearable health monitors with molded components
- Custom molding for portable diagnostic tools
- Compact, lightweight designs for remote patient monitoring devices
As a part of our medical design and device manufacturing, our PCBA and plastic injection molding services support custom designs for specialized complex applications:
- Integrated assemblies for surgical robotics
- Precision-built lab analysis equipment
- More…
Turnkey Box Build Manufacturing Process
Our turnkey box build manufacturing process as a medical device manufacturer offers solutions customized to each stage of product development, helping you bring your ideas to market efficiently and effectively.
Our Core Box Build Manufacturing Services
As a medical device manufacturer, we have a streamlined process for creating high-quality medical devices to facilitate efficient production and assembly. By integrating design, engineering, and manufacturing, we provide a seamless experience that helps bring your products to market quickly and effectively.
Fully integrated assembly solutions for medical devices.
PCB box build assembly services for smart functionality.
Durable, customized enclosures for consumer products.
Cost-effective molds for high-volume consumer production.
Structural and aesthetic components for consumer devices.
Stay Compliant and Competitive By Partnering With a Leading Medical Device Manufacturer
Choosing the right partner for medical design and device manufacturing can significantly impact your product’s success. Our custom manufacturing services bring medical-focused expertise through our strong grasp of the industry’s evolving trends and demands.
With certified quality standards such as ISO 13485 and FDA compliance, we adhere to the highest industry benchmarks. Our USA-based facility is close to the market, enabling quicker turnaround times while maintaining exceptional craftsmanship.
Contact us to partner with a leading medical device manufacturer, reduce design and engineering costs, and experience increased productivity and enhanced product performance.