Medical Device Contract Manufacturing Services for Box Build or Subassemblies

Save Costs, and Outsource your Manufacturing Needs with MFG One

Full-Service Contract Manufacturer for Medical Device

Get Support at Any Stage of the Development Process

From the drawing board to key stages of product development, get the support you need at an affordable price with our open-book pricing. Free up your floor space and reduce overhead costs by outsourcing to MFG One. With extensive expertise across medical and pharmaceutical devices, we’re here to bring your product vision to market with precision and quality.

Check out our services below to see how we can support you on your medical device manufacturing journey.

First Name

Last Name

Phone

Company Name

Country

How Did You Hear About Us?

Please Provide Details About Your Project and How We May Assist You

Our Manufacturing Support Services

Discover how we can help your business grow. Select a service tab to find the perfect solution for your needs.

Our concept and design services take your initial ideas and develop them into robust, manufacturable products ready for the market.

Engineering and Design Services

2D-3D Conversion
Biomedical Engineering Services
Cost Analysis
Design & Development
Electrical & Software Engineering
Electro-Mechanical Engineering
Engineering Support

Failure Analysis & Reliability
FEA (Finite Element Analysis)
Human Factors Engineering
Injection Mold Design
Mechanical Design Services
New Product Introduction (NPI)
Packaging Engineering

Design with manufacturing in mind, providing a smooth transition from concept to production while maximizing efficiency and quality.

Design for manufacturability Services

Optimizing Design for Cost-Effective Production
DFX (Design for Excellence)
DFT (Design for Test)
DFMA (Design for Manufacturing and Assembly)
VAVE Services
Lean Manufacturing

Transform ideas into functional designs with our expert engineering and development services, optimized for real-world applications.

Engineering Services

Product Development
Electro-mechanical Engineering
Tool Engineering
Prototyping Engineering
Manufacturing Process Engineering
Test Engineering

Engineering Capabilities

2D-3D Conversion
Design and Development
Failure Analysis & Reliability
FEA (Finite Element Analysis)
Injection Mold Design
NPI Engineering Plastics
Engineering Product Development
Reverse Engineering

Simulation and Testing
Mechanical Design Services
Value Engineering
Solidworks
Sustaining Engineering
Technical Documentation
Test Development
Software Development Services

Our manufacturing and assembly services deliver your product concepts with accuracy, high quality, and scalability.

Core Capabilities

Secondary Operations

Thorough testing and validation services to help your products meet top performance and compliance standards, with FDA support backed by our legal team.

Testing Services

Vibration
Mechanical Shock
Drop
Mechanical Life
Force, Displacement, and Torque
Environmental
Measurements and Visual Inspection

FDA Support

Validation Services

Verification/Validation of Final Unit
Verification/Validation of Software
Packaging Design/Validation
Risk Assessment
Design Failure Mode and Effects Analysis (DFMEA)
Process Failure Mode and Effects Analysis (PFMEA)

Specialized Validation & Compliance Support

GMP, cGMP, GLP, GAMP
IQ/OQ/PQ
Calibration Management
CFR 21, Part 11 Electronic Signatures, Electronic Records Consulting
Computer system Validation
Design Specification

Requirements Analysis
Risk Assessment
Site acceptance Tests (SAT)
Software Requirements Specifications (URS)
Standard Operating Procedures SOPs
System Validation

Traceability Matrices
User Requirements Specifications (URS)
Validation Gap Analysis
Validation Master Plan Development
Validation Program Management
Vendor Qualification

Our 100,000-square-foot, temperature-controlled facility provides the ideal environment for reliable logistics and fulfillment solutions.

Supply Chain Management

Strategic Commodity Procurement & Supplier Management
Cost Reduction Throughout the Product Life Cycle
End-of-Life Materials Management
EDI/Bonding Programs
Review of Suppliers Quality, Delivery, Pricing

Third Party Logistic (3PL) Services

Inventory Control Systems

Extend the life and reliability of your products with MFG One’s aftermarket support tailored to meet ongoing customer needs.

Aftermarket Support Services

Additional Value Added Services

Turn-Key Complete Box-Build Process

We handle every part of the manufacturing process, start to finish. Whether you need our expertise for a single step or support throughout the entire process, we’re here to help you build quality products that meet your exact standards.

Step 1

DFM: Design For Manufacturability

Step 2

Launch | Prototyping

Engineering Samples
Executes Pilot Runs
Transition Your Product to Full Production
Meet Your Schedules and Overall Demands

Step 3

Production

Once your product is designed and ready for production:

We make sure all issues from the engineering samples and pilot runs have been fully addressed.

Step 4

Ongoing Production

The VA/VE roadmap starts with your product’s evolving needs, to meet changing marketplace requirements.

Step 5

Product Life
Rigorous final checks for optimal market performance.

Step 6

Continuous Improvement

We work with your 12-month rolling product forecast:

VA/VE Teams
Supply Chain Planning
Supply and Cost Competitiveness

Step 7

Cost Savings

Identify Alternative Materials
Refine Production Methods
Drive Out Waste
Establish Lean Manufacturing Processes
Recommend Enhancements

Get Consistent Support from Our US-Based Contract Manufacturing Faciliy

As a U.S. contract manufacturer, we’re here to support customers worldwide. From full-scale production to shipping, partnering with us means fewer delays and no costly tariffs.

Expertise Across Wide Range of Medical & Pharmaceutical Devices

Our expertise across diverse medical and pharmaceutical device ensures your product is engineered and manufactured to the highest quality standards. Our experience encompasses the creation of medical devices, such as the following:

Diagnostics Equipment
Electromechanical Device
Laboratory Equipment
Life Science / Laboratory Products
Patient Care and Monitoring
Personal Use of Medical Devices
Point of use Diagnostics

Healthcare
Patient Monitoring
Drug Delivery
Med Tech
Anesthesia & Respiratory
Surgical Systems
Much More

Medical Devices We Manufactured

Why Outsource With MFG One?

Open Book Costing
Full transparency into material, labor, and overhead costs for better decision-making.

Reduce Operating Costs
Strategies to streamline processes and lower overall expenses.

PCBAs, Plastics, Metals, Full Assembly
Diverse manufacturing services from PCBAs to full assembly, all under one roof.

Program Manager Led Cross-Functional Teams
Dedicated program managers ensure projects stay on track, on budget, and aligned with your goals.

Centralized US-based in Chantilly, VA
Our Chantilly, VA facility supports efficient logistics, fast communication, and quality control for US clients.