FDA-QSR Compliant Medical Device Contract 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.
Variety of Diagnostic Therapeutic and Laboratory Devices We Support
- Diagnostics Equipment
- Electromechanical device
- Laboratory Equipment
- Life Science / Laboratory Products
- Patient care and monitoring
- Personal use medical devices
- Point of use diagnostics
- Healthcare
- Diagnostics
- Patient Monitoring
- Drug Delivery
- Medical Technology
- Anesthesia & Respirator
- Surgical Systems
- Much more…
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 almost a decade 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 contract 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 service contract manufacturing provider, our box-build process integrates every step required to deliver FDA-approved medical device equipment.
Applications We Support But Not Limited To
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 contract 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 printed circuit boards, plastic injection molding and custom metal stamping from our vetted vendors to produce 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. Our in-house team handles design, integration, and assembly, while trusted vendors supply custom-molded and precision parts. 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, we support:
- Integrated assemblies for surgical robotics
- Precision-built lab analysis equipment
- Custom-built medical carts and mobile stands
Turnkey Contract 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.
Box Build Contract Manufacturing Services
Strategic Vendor Partnerships for Device Manufacturing
As a medical device manufacturer, we manage a streamlined process for producing high-quality devices by coordinating with trusted vendors and partners. These managed services support efficient production and assembly, with our team overseeing each phase to integrate design, engineering, and manufacturing for a smooth path to market.
Fully integrated assembly solutions for medical devices.
Vendor-sourced PCBs assembled in-house as part of our box build assembly services.
Durable enclosures sourced through vetted vendors for the best materials and pricing.
Cost-effective molds sourced through trusted vendors for high-volume production.
Structural and aesthetic components sourced through reliable vendors for consumer devices.
Stay Compliant and Competitive By Partnering With a Leading Medical Device Contract 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-QRS 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.