Medical Device Assembly
Precision Assembly. Regulatory Compliance. Traceability Assured.
Medical Device Assembly
What is IT and why is it critical?
Medical Device Assembly is the controlled and documented process of integrating mechanical, electrical, or electronic components into a complete medical device, under validated procedures and in full compliance with applicable quality standards such as ISO 13485 and FDA 21 CFR Part 820. Depending on the complexity and production volume, this process may include manual, semi-automated, or automated techniques. Its purpose is to ensure that each assembled device—whether a high-volume standard product or a customized clinical solution—performs safely and effectively for its intended medical use.
Key Benefits
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Cleanroom Assembly (ISO 7 & 8)
Controlled environments that ensure contamination-free production. -
Manual & Semi-Automated Assembly
Skilled technicians handle delicate components with precision and consistency. -
Custom Tooling & Fixtures
Designed for repeatability, ergonomic safety, and error-proofing during complex assemblies. -
In-Process Quality Control (IPQC)
Continuous inspection and testing during assembly to ensure product integrity. -
Traceability & Documentation
Full lot traceability, Device History Records (DHRs), and compliance with regulatory standards. -
Packaging & Sterilization Prep
Final packaging under cleanroom conditions, with readiness for terminal sterilization if required.
Key Factors
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Cleanroom Certified Environments
Assembly in ISO Class 7 and 8 cleanrooms to maintain product sterility and prevent contamination. -
Consistent Workmanship
Personnel trained to follow standardized work instructions and validated procedures. -
Full Process Traceability
Documentation of components, assembly steps, and lot records aligned with quality audits. -
Integrated Quality Control
In-process and final inspections to verify compliance with specifications. -
Regulatory Documentation
Availability of assembly instructions, DHRs, and batch records supporting FDA and ISO requirements.
Certifications
RexMed's Competitive Edge
RexMed specializes in the precise assembly of high-complexity devices under cleanroom conditions. Our experience covers a wide array of assembled products, including a broad range of medical devices, such as IV therapy sets, enteral containers, hospital tubing sets, surgical kits, dispenser coils and urological drainage bags among others.
Our cleanroom operations, combined with in-process quality controls and full traceability, enable us to meet strict compliance requirements for OEMs, hospitals, and distributors operating under FDA and ISO frameworks.
Ensure precision, traceability, and compliance from the first component.
Partner with RexMed for certified medical device assembly.
FAQ
Do you offer finishing services?
Yes. We offer cutting, tipping, printing, and forming to deliver complete, ready-to-use tubing and tubing sets.
Is extrusion performed in a clean environment?
Yes. All tubing is produced in an ISO Class 8 cleanroom.
What size range do you support?
External diameters from 0.050” to 0.5”, with variable lengths.
What types of tubing configurations are available?
Single-lumen and multi-lumen, including striped, jacketed, and radiopaque.
What materials does Rexmed extrude?
PVC, EVA, PE, and PP.