Medical Device Assembly
Arterex Medical is a medical device manufacturer providing medical device assembly and packaging services that span the full production lifecycle — from individual components to complete, market-ready finished products. With a commitment to precision, regulatory compliance, and patient safety, Arterex Medical serves as a single, accountable manufacturing partner for medical device companies at every stage of production.
Arterex Medical’s assembly capabilities cover a wide range of specialized services including clean room assembly in ISO-certified Class 7 and Class 8 environments, electromechanical assembly, micro assembly, sub-assembly, full device builds, and automation-assisted production. The company also provides complete turnkey manufacturing solutions, managing everything from design for manufacturability reviews through to final packaged product under one roof.
The assembly process at Arterex Medical follows a structured, repeatable framework built around quality and compliance. It begins with an initial consultation and requirements review, moves through DFM review, material sourcing, process development, pilot builds, and full clean room production, and concludes with in-process inspections, functional testing, sterile packaging, final quality review, and ongoing continuous improvement support.
What sets Arterex Medical apart is its depth of regulatory knowledge and operational discipline. The team applies FDA 21 CFR Part 820, ISO 13485, and global regulatory standards at a working level, giving clients fewer compliance gaps and faster market submissions. Production scales from early-stage clinical builds to full commercial volumes without compromising quality or turnaround time.
Arterex Medical’s certification framework reinforces every aspect of its manufacturing operations. Key certifications and compliance standards include ISO 13485:2016, FDA Registration, ISO 14971:2019, ISO 11607, ISO 10993, ISO 9001:2015, IQ/OQ/PQ process validation, and EU MDR compliance support. These certifications reduce the regulatory burden on clients, simplify supplier audits, and ensure every device is built within a system designed to protect patient safety from the first build to the last shipment.
What Are Our Comprehensive Medical Device Assembly Capabilities?
We assemble complex medical devices with precision, speed, and full regulatory compliance — from individual components to complete finished products ready for market. Our capabilities span the full production lifecycle, giving you a single, accountable manufacturing partner at every stage.
Clean Room Assembly
Our ISO-certified clean rooms provide a controlled, contamination-free environment essential for sensitive medical device production. We operate Class 7 and Class 8 clean room facilities suited for implantables, diagnostic equipment, and fluid-path components. Every workstation, material, and process follows strict contamination control protocols to protect product integrity and patient safety.
Electromechanical Assembly
We integrate printed circuit boards, sensors, motors, actuators, and wiring harnesses into fully functional medical systems. Our technicians are trained to handle complex electromechanical builds that demand both mechanical precision and electrical accuracy. Every completed assembly undergoes rigorous electrical testing and performance validation to confirm it meets your exact design specifications before shipment.
Micro Assembly
We specialize in assembling miniaturized medical components with tolerances measured in microns. This capability directly supports the production of catheters, endoscopes, hearing devices, ophthalmic instruments, and other high-precision products. Our technicians use magnification systems, specialized tooling, and controlled handling techniques to ensure accuracy and consistency across every micro-scale build.
Sub-Assembly & Full Device Build
We manage both sub-assembly production and complete end-to-end device builds within a single facility. Consolidating these operations under one roof reduces your supply chain complexity, minimizes handoff risks, and shortens overall time to market. From mechanical sub-systems to fully integrated finished devices, we maintain tight quality control at every stage of the build process.
Automation-Assisted Assembly
Our automated assembly lines combine robotic precision with high-volume production capacity. Automation reduces human error, improves repeatability, and maintains consistent output quality across large production runs. We deploy automated torque application, adhesive dispensing, vision inspection systems, and component placement to ensure every device meets the same exacting standard, batch after batch.
Validation & Testing
Every device we manufacture passes through structured functional, mechanical, and electrical testing protocols before release. We support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation activities to satisfy FDA and ISO 13485 requirements. Our testing processes are fully documented, traceable, and audit-ready, giving you complete confidence in product performance and regulatory standing.
Packaging & Sterile Barrier Assembly
We assemble and package medical devices using processes specifically designed to preserve sterility throughout the entire supply chain. Our sterile barrier assembly operations comply with ISO 11607, covering material selection, seal integrity testing, and packaging validation. Proper packaging — protects — product sterility from the point of manufacture all the way through to the end user.
Contract Manufacturing & Turnkey Solutions
We offer complete turnkey manufacturing solutions, taking your product from design for manufacturability (DFM) review through to final packaged, shelf-ready product. Our team manages sourcing, assembly, testing, validation, and packaging under one contract, giving you full accountability without juggling multiple vendors. This streamlined approach reduces cost, compresses lead times, and keeps your project moving forward efficiently.
What is Our Process for Medical Device Assembly?
Every medical device we assemble follows a structured, repeatable process built around quality, compliance, and precision. From the first conversation to final shipment, we manage every step with full transparency and accountability.
1. Initial Consultation & Requirements Review
We begin by understanding your device, your production goals, and your regulatory requirements. Our engineering team reviews your specifications, drawings, and compliance documentation to identify the best path forward. This early alignment prevents costly errors downstream and ensures every decision made throughout the project serves your product’s clinical and commercial intent.
2. Design for Manufacturability (DFM) Review
Before production begins, we evaluate your design through a manufacturability lens. Our team identifies potential assembly challenges, material incompatibilities, or tolerance issues that could affect yield or quality. We work directly with your engineering team to recommend practical design adjustments that improve assembly efficiency without compromising device performance or regulatory compliance.
3. Material Sourcing & Supply Chain Management
We source components and raw materials from qualified, audited suppliers that meet medical-grade standards. Every material entering our facility is verified against your bill of materials (BOM) and inspected upon receipt. We manage supplier relationships, lead times, and inventory levels to keep your production schedule on track and your supply chain free of disruption.
4. Process Development & Validation Planning
We develop and document the assembly process specific to your device before a single production unit is built. This includes defining work instructions, tooling requirements, inspection checkpoints, and validation protocols. A well-documented process — ensures — consistent output and provides the traceability regulators expect during audits and submissions.
5. Pilot Build & Process Validation (IQ/OQ/PQ)
We run a controlled pilot build to validate the assembly process under real production conditions. Installation Qualification (IQ) confirms equipment is set up correctly. Operational Qualification (OQ) verifies the process performs as intended. Performance Qualification (PQ) demonstrates consistent, repeatable results at production volume. All validation activities are fully documented and audit-ready.
6. Clean Room Assembly & Production
Approved and validated processes move into full production within our ISO-certified clean room environments. Our trained technicians follow controlled work instructions, use qualified tooling, and operate within strict environmental monitoring parameters. Every workstation and operator is qualified, and every build is executed to the same standard — whether you need 100 units or 100,000.
7. In-Process Inspection & Quality Control
Quality checks are embedded throughout the assembly process, not just at the end. We perform in-process inspections at defined intervals to catch non-conformances early and prevent defective units from progressing through the line. Inspection data is recorded in real time, giving you complete visibility into production quality at every stage of the build.
8. Functional & Performance Testing
Every completed device undergoes functional and performance testing before it advances to packaging. We test your validated test protocols, covering electrical performance, mechanical integrity, fluid path function, and any device-specific parameters. Testing — confirms — that each unit performs exactly as designed under the conditions it will face in clinical use.
9. Packaging & Sterile Barrier Assembly
Finished devices are packaged using validated processes that maintain product integrity and sterility through the supply chain. We follow ISO 11607 guidelines for sterile barrier system design, seal integrity testing, and packaging validation. Labeling is reviewed for accuracy and regulatory compliance before any unit is approved for release.
10. Final Quality Review & Product Release
Before shipment, every batch undergoes a comprehensive final quality review. Our quality team verifies that all documentation, test records, inspection data, and batch records are complete, accurate, and traceable. Only devices that fully satisfy your acceptance criteria and our internal quality standards are approved for release and dispatched to your customer or distribution network.
11. Ongoing Support & Continuous Improvement
Our relationship does not end at shipment. We monitor production data, track non-conformance trends, and apply continuous improvement methodologies to refine your assembly process over time. If your device evolves or your volume scales, we adapt our process with you — keeping quality consistent and costs controlled at every stage of your product’s lifecycle.
Our process is designed to give you confidence at every step — from the first design review to the final shipment. We bring structure, discipline, and genuine manufacturing expertise to every medical device assembly project we take on.
Why Choose Arterex Medical for Medical Device Assembly Services?
Choosing the right contract manufacturing partner for your medical device is one of the most consequential decisions you will make. Arterex Medical brings the technical depth, regulatory expertise, and production discipline to get your device built right — on time, every time.
ISO 13485 Certified Quality Management
Arterex Medical operates under a fully implemented ISO 13485 certified quality management system. This certification is not a formality — it governs every process, every decision, and every output across our facility. Your device is built within a quality framework specifically designed for the medical device industry, giving you the regulatory confidence you need from day one.
Deep Regulatory Knowledge
We understand FDA 21 CFR Part 820, ISO 13485, and global regulatory requirements at a working level — not just on paper. Our quality and engineering teams apply this knowledge directly to your assembly process, documentation, and validation activities. This means fewer compliance gaps, faster submissions, and an assembly partner that speaks the same regulatory language as your team.
Experienced, Highly Trained Technicians
Our assembly technicians are trained specifically for medical device manufacturing. They understand the precision, discipline, and attention to detail that this industry demands. Every technician is qualified to perform the specific tasks assigned to them, and their training records are fully documented and audit-ready. Skilled hands — build — reliable devices.
End-to-End Turnkey Manufacturing
Arterex Medical manages the full production lifecycle under one roof. From DFM review and material sourcing through assembly, testing, validation, packaging, and final release — we handle it all. A single, accountable partner simplifies your supply chain, reduces handoff risk, and gives you one point of contact for every aspect of your manufacturing program.
Scalable Production for Any Volume
Whether you are producing early-stage clinical units or scaling to full commercial volumes, our production infrastructure scales with your needs. We support low-volume pilot builds, mid-volume production runs, and high-volume commercial manufacturing without sacrificing quality or turnaround time. Your production program grows with your business, not against it.
Robust Validation & Testing Protocols
We support full IQ, OQ, and PQ validation activities with complete documentation at every stage. Our in-house testing capabilities cover functional performance, electrical integrity, mechanical strength, and device-specific parameters. Every test is executed against your validated protocols, and every result is recorded with full traceability. Validation — protects — your product, your patients, and your regulatory standing.
When you choose Arterex Medical, you are not just selecting a contract manufacturer. You are choosing a partner committed to the quality, compliance, and performance of your medical device from the first build to the last shipment.
Our Certifications for Medical Device Assembly
Every device we assemble is backed by a rigorous certification framework that meets international regulatory standards. Our certifications are not badges on a wall — they are active, audited commitments that govern how we design processes, manage risk, control quality, and protect patient safety every single day.
ISO 13485:2016 — Medical Device Quality Management System
ISO 13485 is an internationally recognized standard that defines the requirements for a quality management system specific to the medical device industry. This is the foundation of everything we do at Arterex Medical. Our ISO 13485:2016 certification confirms that our processes for design transfer, assembly, testing, validation, and product release all operate within a documented, audited quality management system. It aligns closely with FDA requirements and is recognized by regulators worldwide, giving your device a compliance head start in every major market.
FDA Registration — 21 CFR Part 820 Compliance
The FDA requires all contract manufacturers of finished medical devices to register their facility and list their products, regardless of whether they place the device into commercial distribution directly. Arterex Medical is a fully registered FDA contract manufacturer operating in compliance with 21 CFR Part 820, the Quality System Regulation governing medical device manufacturing in the United States. This registration means every device we produce meets the Current Good Manufacturing Practices (CGMP) the FDA expects, and that we are fully accountable under U.S. federal regulation.
ISO 14971:2019 — Risk Management for Medical Devices
ISO 14971 specifies the process manufacturers must follow to identify hazards associated with medical devices, evaluate the risks those hazards present, and implement effective risk controls across all stages of the device lifecycle. At Arterex Medical, risk management is embedded into every stage of the assembly process — not addressed after the fact. We apply ISO 14971 principles during process development, design transfer, material selection, and validation planning to ensure that every potential hazard is identified, evaluated, and controlled before it can reach a patient.
ISO 11607 — Sterile Barrier System & Packaging Validation
ISO 11607 sets the requirements for materials, sterile barrier systems, and packaging validation for medical devices that must be sterilized and maintained in a sterile condition through to the point of use. Our packaging operations at Arterex Medical are fully validated to ISO 11607 requirements. This covers material qualification, seal integrity testing, packaging system validation, and shelf-life assessment. Every sterile device we package maintains its sterile barrier from the point of assembly through to the point of clinical use — with full documentation to prove it.
ISO 10993 — Biological Evaluation of Medical Devices
ISO 10993 provides the framework for evaluating the biological safety of medical devices, covering risk assessment, biocompatibility testing, and material evaluation to assess the potential impact of a device on patient health. Arterex Medical applies ISO 10993 principles to material selection and process development for all devices involving patient contact. We ensure that every material used in your device has been evaluated for biocompatibility and that no manufacturing process introduces biological risk that could harm the patient.
ISO Cleanroom Classification — Class 7 & Class 8 Environments
ISO cleanroom classifications define the acceptable levels of airborne particulate contamination within a controlled manufacturing environment, ranging from the most stringent Class 5 environments for sterile device assembly through to Class 8 for non-sterile component fabrication. Arterex Medical operates both Class 7 and Class 8 certified clean room environments to support the contamination control requirements of a wide range of medical device types. Our clean rooms are continuously monitored and documented, ensuring every assembly takes place in a validated, controlled environment that protects product integrity and patient safety.
ISO 9001:2015 — Quality Management System Foundation
ISO 9001:2015 establishes the foundational principles of an effective quality management system, ensuring that processes consistently result in the design, production, and delivery of products that meet customer and regulatory requirements. While ISO 13485 supersedes ISO 9001 for medical device manufacturing, our quality management system is fully aligned with ISO 9001:2015 principles. This alignment reinforces our commitment to continuous improvement, customer satisfaction, and process discipline across every function in our facility.
IQ / OQ / PQ Process Validation
Installation Qualification, Operational Qualification, and Performance Qualification validation protocols are a formal requirement within our quality management system for every new assembly process and every significant process change. IQ confirms that equipment is installed and configured correctly. OQ verifies that the process performs as intended across its full operating range. PQ demonstrates that the process produces consistent, conforming output under real production conditions. Every validation protocol and report is fully documented and available for regulatory review at any time.
EU MDR Compliance Support — European Market Readiness
The European Union Medical Device Regulation (EU MDR 2017/745) sets some of the most demanding medical device manufacturing requirements in the world. Arterex Medical’s quality management system and certification framework are structured to support EU MDR compliance requirements, including technical documentation, clinical evidence, post-market surveillance, and full device traceability — helping you access European markets with confidence and without unnecessary regulatory delay.
Our certifications translate directly into practical advantages for your device program. They reduce your regulatory burden, simplify your supplier audits, support your market submissions, and give your quality team the documentation they need. Most importantly, they mean every device assembled at Arterex Medical is produced within a system specifically designed to protect the safety of the patients who will use it.
Certification — demonstrates — commitment. At Arterex Medical, that commitment is verified, audited, and renewed continuously.