Accelerate Market Entry

Turnkey Biotechnology Manufacturing Services

MFG One’s turnkey biotechnology manufacturing services simplify the product build process while reducing total costs by combining professional engineering, strategic vendor management, and in-house, US-based production.

A biotech engineer working at MFG One’s facility, a chosen partner for turnkey biotechnology manufacturing services.

One Team. All the Moving Parts. No Operational Gaps.

From design input and sourcing to system integration and final delivery, we oversee your complete biotech build. As an ISO 13485 and FDA QSR compliant team, we leverage specialized vendors for fabrication while managing final integration, testing, and logistics in-house.
Here’s what you can expect from a leading provider of medical device design and manufacturing:

Biotech Systems and Electronic Components We Support

Through our custom manufacturing services, we help OEMs, medtech teams, and research labs bring advanced, regulated concepts to market.

Life Science Equipment

Devices used in genomics, proteomics, and cell analysis workflows.

Modular or cartridge-based assemblies supporting clinical or point-of-care testing.

Sensor-integrated components, pump and flow modules, and control units.

Devices for chemical, biological, or pharmaceutical research.

Control and sensing units used in regulated or sensitive environments.
A biotech engineer verifying details in a US-based facility owned by MFG One, a leading provider of turnkey biotechnology manufacturing services.

Cross-Functional Support for Regulated and Technical Builds

Bringing a biotech product to market takes tight coordination across engineering, compliance, and production. As a turnkey biotechnology manufacturing service provider, our process bridges design and delivery to reduce delays and costs while giving you full visibility into your build.

Concept Refinement and Engineering Support

In our prototype development services, our team of adept engineers works at the intersection of usability, manufacturability, and compliance.

Prototyping and DFMA

Testing form, fit, and function, while applying DFMA principles to reduce complexity, shorten assembly time, and avoid downstream adjustments.

Supply Chain and Vendor Management

Sourcing components based on material compatibility and lead time while actively managing supplier communication, schedule tracking, and quality checks.

Assembly, Testing, and Validation

Final system builds in our U.S.-based facility with hands-on assembly, traceable testing, and built-in documentation.

Compliance-Driven Packaging and Labeling

As an ISO 13485 and FDA QSR compliant team, we manage labeling, tracking, and documentation with precision.

Warehousing, Fulfillment, and Lifecycle Support

Our product lifecycle services include inventory management, coordinating drop shipments, managing long-term service parts, and revision changes.

Focus on Product Performance, We’ll Handle the Rest

At MFG One, we structure your build for control, clarity, and forward momentum. Our turnkey biotechnology manufacturing services blend in-house integration with meticulously sourced components, so every part of the build supports your performance goals.

Get quick feedback loops, centralized quality control, and smoother transitions between design, build, and shipment. Our U.S.-based facility manages critical phases directly, enabling greater oversight, real-time adjustments, and full traceability.


  • Risk analysis and test planning aligned to your specs

  • Mechanical and electrical system integration

  • Reverse engineering services

  • Functional testing with documented results by unit or batch

  • Cleanroom-compatible assembly and inspection (coming soon)

  • Final QA, serialization, and revision control

  • Logistics planning and outbound coordination

  • Entire product lifecycle support

We source from proven suppliers selected for their material expertise and technical alignment with your product. For new product introduction services, our vendor network gives you greater control, consistent quality, and competitive pricing that supports your bottom line.

  • PCB fabrication and population through contract manufacturing electronic assembly partners
  • Injection-molded or formed plastic components
  • Sensors, modules, and fluidic parts with validated specs
  • Specialized enclosures, shielding, and thermal structures
  • Cable harnesses and electrical interconnect systems

Why Our Workflow for Turnkey Biotechnology Manufacturing Services Work

Our box build assembly services for life sciences and pharma follow a clear, coordinated process that supports both design intent and production demands. As an ISO 13485 and FDA-QSR compliant contract manufacturer, we combine hands-on control with strategic outsourcing to protect engineering integrity, shorten lead times, and maintain quality throughout.

You get the reach of a qualified supplier network with the focus and accountability of a centralized team. Benefit from a turnkey biotechnology manufacturing service provider like MFG One and experience:

Purpose-Built for Regulated Products That Can’t Afford Delays

Biotech product teams work under strict deadlines, evolving regulations, and complex design requirements. Our turnkey biotechnology manufacturing services are structured to keep pace, help you stay aligned, avoid slowdowns, and maintain control as your product moves from prototype to production.

Here’s how our custom electronic design services for biotech balance efficiency and cost:

High-Performance Support for High-Stakes Industries

The accuracy and coordination that define our turnkey biotechnology manufacturing services extend across every sector we serve. At MFG One, you get the same focused execution and production confidence, no matter the industry or complexity of the build.

Medical and Life Sciences

 Regulated apparatus including diagnostic equipment, lab instrumentation, and therapeutic devices.

Electronic assemblies, sensor modules, and control systems for EV and mobility platforms.

Embedded controls, enclosure assemblies used in industrial, robotics, and process equipment.

Power and signal management units, infrastructure components, and network-ready subsystems.

Inverter systems, storage control units, and field-deployable electronics built for solar, wind, and grid applications.

Shorten Lead Times and Optimize Costs with MFG One

Biotechnology manufacturing requires careful coordination, documented quality controls, and the ability to adapt without affecting timelines.

With MFG One, your team can advance through production phases without setbacks, missed timelines, or fragmented sourcing networks. With two decades of experience in electronic contract manufacturing for life sciences, diagnostics, and more, we’re a true manufacturing partner known for our precision, insight, and responsiveness.

If you’re located in the US, Canada, the UK, Mexico or anywhere in the world, we can help you meet compliance while saving operational costs. Get a free quote on our turnkey biotechnology manufacturing services for a seamless biotech product journey.