USA's Leading Contract Medical Device Manufacturer

Your trusted source for medical device equipment. 

We Offer a Full Range of
Contract Manufacturing Services

MFG One is your contract manufacturer, specializing in medical devices. We bring decades of experience to deliver full-service contract manufacturing, from initial concept to final production. Let us guide your product’s journey with our expertise in design, engineering, and manufacturing.

MFG One's Certifications

FDA Registration Certification

ISO 13485
Certification

louisiana board of drug and device distributors logo

louisiana board of drug and device distributors Certification

Virginia Board Pharmacy

Virginia Board Pharmacy Permit

Our Diverse Range of Medical Devices

As a full-service contract medical device manufacturer, we specialize in the design, development, and engineering of innovative medical devices for healthcare professionals worldwide. Our expertise spans a variety of essential equipment, ensuring that we provide comprehensive support and cutting-edge solutions to meet the healthcare industry’s ever-evolving needs.

  • 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
  • ThermaCor® 1200 Rapid Infuser
  • Heat-Stack® Fluid Warming System
  • Cocoon™ Convective Patient Warming System
  • 16N1® Fluid Warming System
  • 8N1® Fluid Warming System

Engineering, Design & Development

As your contract medical device manufacturer, we transform your vision into tangible concepts, optimizing for functionality, manufacturability, and regulatory compliance.

Prototyping

Rapid prototyping techniques enable swift iterations to refine your design, accelerating the path to market.

New Product Introduction or Existing Product

Whether launching a groundbreaking device or revamping a legacy product, we ensure a seamless transition maintaining continuity and excellence throughout the process.

Testing, Validation & Verification

Rigorous testing ensures your device meets performance, safety, and regulatory standards.

Manufacturing

Our precision manufacturing delivers consistent quality products at scale, adhering to the strictest standards.

Aftermarket Support

We provide ongoing aftermarket medical device support including repairs, replacement parts, product upgrades, and 3PL services.

We Transform Your Concepts into Market-Ready Products

Got a brilliant idea sketched out on a napkin? As a leading contract medical device manufacturer, MFG One can breathe life into your vision. Our experienced engineers will collaborate closely with you to turn that concept into a fully realized medical device. 

We’ll leverage our deep understanding of medical device design principles to optimize your product for functionality, manufacturability, and user experience. This ensures your device not only performs but can also be produced efficiently and cost-effectively.

The medical device industry is governed by a complex regulatory process, and we understand it like the back of our hands. We’ll expertly navigate FDA requirements and other applicable regulations, ensuring your product adheres to the strictest safety and quality standards. 

If you are looking for a full-service contract medical device manufacturer who can bring your ideas to life and expedite your time to market, contact MFG One today to schedule a free consultation.

Project Management

Successful medical device development demands meticulous project management. As a premier contract medical device manufacturer, MFG One understands that open communication, proactive risk mitigation, and adaptable processes are critical in a heavily regulated industry. That’s why we approach project management with exceptional care.

Dedicated Project Manager

Your dedicated project manager acts as your primary point of contact, providing proactive updates and ensuring accountability across all stages.

Open Communication

Transparent and consistent communication builds trust and ensures your expectations are met, reducing the likelihood of unwelcome surprises.

Agile Development

We blend traditional project management with agile methodologies to adapt quickly to changing requirements while maintaining rigorous quality control.uct evolves with the market.

Risk Mitigation

We have proactive identification and mitigation processes in place for potential risks throughout the development process to keep your project on track and within budget.

Still searching for a medical devices product development company? Let MFG One manage the complexities of your project, so you can focus on the most essential task: bringing an innovative product to market. Schedule your free consultation today!

Why Choose MFG One as Your Contract Medical Device Manufacturer

Choosing the right FDA-registered medical device manufacturers can be the difference between success and disappointment. At MFG One, we go beyond simply manufacturing your product; we become an extension of your team. Our commitment to quality, collaboration, and efficiency gives you a decisive competitive advantage in a demanding marketplace. Here’s how:

Expertise

Deep knowledge of medical device development and manufacturing processes, ensures your product is built right the first time

Streamlined Process

Efficient, end-to-end solutions accelerate your time to market, allowing you to capitalize on opportunities faster.

Quality Commitment

Meeting the highest standards of quality throughout our process, safeguarding both your patients and your reputation.

Regulatory Compliance

Ensuring your products adhere to FDA and other applicable regulations, minimizing costly delays and setbacks.

Customer Focus

A collaborative, flexible, and dedicated approach to your project, prioritizing open communication and adaptability to your unique requirements.

Track Record

A history of successfully bringing medical devices to market, providing peace of mind, and demonstrating our capabilities.

Contact MFG One for Cutting-Edge Medical Device Design and Manufacturing Solutions

MFG One understands the critical role medical devices play in people’s lives. As a premier contract medical device manufacturer in the USA, we are relentlessly focused on quality, reliability, and innovation to bring your products to those who need them. Our commitment to exceeding your expectations forms the foundation of our partnerships.

We are a premier contract manufacturing organization servicing businesses nationally and internationally including but not limited to the US, Canada, United Kingdom, and Mexico. Ready to bring your medical device to life? Contact us today and let MFG One power your success!