Cleanroom Contract Manufacturing
MFG One is a box-build contract medical device manufacturer that offers ISO Class 7 cleanroom for sterile and non-sterile devices. Our versatile cleanroom facility is dedicated to design, engineering, manufacturing, assembly, and packaging of medical devices.
FDA-Compliant Cleanroom for Medical Equipment Manufacturing
As a leading provider of cleanroom contract manufacturing , MFG One delivers precision, speed, and full-spectrum solutions for your most critical medical device manufacturing needs.
- Accelerate Your Time to Market: From prototyping to full-scale production, our integrated cleanroom supports faster product launches.
- Scalable Production with Fast Turnarounds: Our modular cleanroom infrastructure quickly adapts to changes in volume and product mix, maintaining short lead times and operational flexibility.
- Zero-Defect Track Record Since 2017: Our medical device design manufacturing services include complex full build assembly, with 8+ years of defect-free output and consistency.
- Compliance-Driven, Quality-Focused: Our ISO 13485-certified operations are aligned with FDA and international standards for medical device manufacturing.
Advanced Cleanroom Facility in the USA Built for Box Build Medical Device Assembly
Our cleanroom contract manufacturing solutions support a broad range of device types, from packaging and subassembly to final build with our ISO Class 7 and ISO Class 8 validation. Class 8 environments are ideal for upstream processes like component preparation and packaging, while Class 7 zones are designated for sterile assembly and high-risk medical builds.
Our cleanroom infrastructure is engineered for particulate, microbial, and environmental control at every level. We maintain a tightly regulated environment to maintain product consistency, compliance, and performance.
Whether preparing for a regulatory filing, third-party audit, or FDA inspection, our cleanroom contract manufacturing records are always ready for review.
Our Capabilities in Medical Device Box Build and Assembly
As leading box build assembly contract manufacturers for medical devices, our ISO-certified cleanroom and controlled environment facility handles the fabrication of medical-grade foams, films, and specialty materials for critical applications. These facilities feature advanced processing technologies to prepare materials for use in sterile and contamination-sensitive environments.
Our cleanroom contract manufacturing solutions deliver custom components, packaging, and fully operational top-tier medical devices worldwide.
- → Compression Molding: Shapes medical-grade foams and polymers under heat and pressure for high-consistency, high-volume parts.
- → PCB Box Build Assembly Services: Facilitating design and assembly of complex parts of medical devices for optimal functionality.
- → Vacuum Forming: Form rigid films into precise shapes for trays, enclosures, and sterile packaging applications.
- → High-Speed Die Cutting: Rapidly cuts complex geometries with tight tolerances for foams, films, and layered materials.
- → Cleanroom Laundering: Removes particulates and residues from materials to meet Class 7 and Class 8 cleanroom standards.
- → Surgical Instruments and Tools: Handheld or powered devices used in operating rooms, designed for durability, sterility, and precision during invasive procedures.
- → Diagnostic and Monitoring Devices: Non-invasive and minimally invasive systems such as patient monitors, test kits, and point-of-care diagnostics requiring contamination-free builds.
- → Implantable Devices (Orthopedic, Cardiovascular, Neurological): Permanent or semi-permanent implants, including stents, joint replacements, and neurostimulators, requiring sterile assembly and absolute quality control.
- → Drug Delivery Systems (e.g., inhalers, injectors): Single and multi-use devices like fluid warming systems, auto-injectors, inhalers, and infusion systems that must maintain drug stability and meet strict sterility requirements.
- → Custom-engineered packaging materials and sealing methods that preserve sterility from cleanroom to point of use.
- → Fully traceable labeling solutions to meet UDI and global compliance standards.
- → Collaborative Engineering Support: Early-stage design input and PCB reverse engineering services to reduce risk and optimize for cleanroom assembly from the start.
- → Value-Added Cleanroom Services: Comprehensive in-house offerings such as kitting, functional testing, inspection, and final packaging, all performed within controlled environments.
Quality Assurance and Process Control in Cleanroom Contract Manufacturing
Biomedical device manufacturing hinges on contamination-free surroundings to safeguard product integrity and function. While contamination is a quality issue, it can pose a serious risk to patient safety and compromise your goodwill. Thus, cleanroom contract manufacturing is the only path forward for medical device OEMs. At MFG One, our advanced cleanroom facility based in the USA eliminates risk with high-efficiency airflow systems, strict gowning protocols, and continuous monitoring.
While speeding up the time-to-market of your medical device, we reinforce regulatory compliance and uphold product integrity.
- Environmental Monitoring: Our microbiological team routinely monitors temperatures and particulate levels for keeping contamination under control.
- Process Validation: Our assembly processes are validated using IQ/OQ/PQ protocols. We apply statistical process control (SPC) to maintain repeatability and detect deviations early.
- Traceability and Documentation: Every material, lot, and process step is traceable from intake to shipment. Detailed documentation supports FDA audits and global regulatory submissions.
- Risk Management: We proactively assess and mitigate risks specific to cleanroom manufacturing with CAPA protocols for swift correction of deviations and long-term process integrity.
Why Entrust Your Cleanroom Medical Device Manufacturing to MFG One
Every detail matters in life-saving medical device manufacturing — from air control to precision assembly. MFG One ensures seamless integration and regulatory compliance to bring your concept to market confidently.
- Single-Source Efficiency: Streamlined from design to delivery.
- U.S.-Based Advantage: Fast shipping and real-time collaboration.
- Transparent and Controlled: Live dashboards and inventory tracking.
- Built-In Compliance: FDA and ISO 13485 ready.
- Risk-Resilient Protocols: Validated processes and contamination control.
Let’s Build Your Next Breakthrough
MFG One is proud to be a contract manufacturer in the USA. We support medical OEMs globally, including the United States, Canada, United Kingdom Mexico and beyond with our expertise in cleanroom contract manufacturing to accelerate your product success. We go beyond standard contract manufacturing to offer a partnership built on performance, protection, and accuracy.
Have a project in mind? Let’s get you started with custom manufacturing services for medical devices. Contact us for a free consultation to help you explore timelines, materials, regulatory pathways, and production options.