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Manufacturing
Services

LEADING
INNOVATION

Delivering end-to-end production excellence from
small-scale builds to commercial volumes.

OVERVIEW

Precision Manufacturing for Critical Medical Applications

Cirtec is more than just a manufacturing partner; we are an extension of your team, delivering complete end-to-end support for medical device development. From initial design through to full-scale production, our vast network of facilities, including over 300,000 square feet of engineering and production space, allows us to manage everything in-house—ensuring quality, consistency, and speed at every stage. Our manufacturing specialties include:

  • Catheter Delivery Systems: High-precision manufacturing for multi-lumen, deflectable, and braided catheters, ensuring tight tolerances and advanced handle designs for structural heart and neurovascular applications.
  • Application-Specific Integrated Circuits (ASICs): Custom-designed ASICs that enable miniaturization, power efficiency, and enhanced functionality in active implantable devices.
  • Thin-Film and Flexible Circuits: Design and production of ultra-miniature circuits, sensors, and electrodes to meet the specific needs of implantable and minimally invasive devices.
  • Leads Design & Manufacturing: Comprehensive capabilities for manufacturing leads, including paddle, percutaneous, and cuff designs for neuromodulation and cardiac applications.
  • Active Implantable Devices: Expertise in producing complex devices such as implantable pulse generators (IPGs), pacemakers, defibrillators, and ventricular assist devices (VADs) for therapies in neuromodulation, cardiac rhythm management, and circulatory support.
  • Nitinol Tubing & Processing: Expertise in producing durable, flexible Nitinol components used in minimally invasive devices, including stents and catheter-based systems.
  • Precision Machining & Metal Stamping: High-precision Swiss turning, wire EDM, and stamping services to create intricate components for complex medical devices.
  • Micro-electronics Assembly: ESD-safe environments and hermetic welding for the production of active implants and other high-precision electronic devices.
  • Laser Welding, Marking, Etching, and Cutting: Precision laser services to enhance product detail and ensure the highest quality for implantable and electronic medical devices.
  • Silicone & Epoxy Molding: Molding and backfilling services to support components in active implants, surgical devices, and catheter systems.
  • Sterile and Non-Sterile Packaging: In-house sterilization management or third-party sterilization support to meet regulatory and global standards for medical devices.
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precise fabrication

Comprehensive
Manufacturing Solutions

SERVICES & Support
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Manufacturing

Cleanroom Manufacturing

Our ISO-certified Class 7 and 8 cleanrooms provide controlled environments for manufacturing sensitive medical devices that require contamination control and regulatory compliance.

Continuous environmental monitoring ensures particulate levels remain within strict specifications.

Validated processes maintain sterility and product integrity throughout assembly and packaging operations.

Trained cleanroom technicians follow rigorous protocols to minimize contamination risks during manufacturing.

Documented controls meet FDA and ISO requirements for implantable and sterile medical devices.

Sterilization Management

Our comprehensive sterilization services ensure medical devices meet stringent sterility requirements through validated processes, regulatory compliance, and complete documentation.

In-house EO sterilization provides quick-turn options for research, clinical trials, and production needs.

Validation protocols verify sterilization effectiveness while preserving product functionality and materials.

Sterile package design maintains barrier integrity throughout transportation, storage, and handling.

Documented sterilization processes support regulatory submissions with comprehensive test data.

Device Assembly

Our comprehensive assembly capabilities integrate complex components into finished medical devices with precise specifications, rigorous quality control, and regulatory compliance.

Skilled technicians perform intricate manual assembly for components requiring dexterity and precision.

Automated systems ensure consistency and high throughput for repetitive assembly operations.

Subassembly and
Secondary Operations

We deliver specialized processes that enhance component functionality and prepare subassemblies for final integration, ensuring quality at every stage of your device manufacturing.

Precision welding and bonding techniques create reliable connections between diverse materials.

Surface treatments improve biocompatibility and performance characteristics of component interfaces.

Heat treating and annealing optimize mechanical properties for specific device applications.

Validated inspection methods verify subassembly specifications before integration into finished devices.

EXPERTISE
MANUFACTURING SERVICES

Precision Manufacturing
Excellence

  • End-to-end capabilities ensure quality at every stage
  • Lean manufacturing and continuous improvement reduces cost and improves yields
  • Cleanroom facilities for sensitive medical production
  • Scalable solutions from trials through commercial launch

Cirtec's global manufacturing network spans over 300,000 square feet of production space, including ISO-certified cleanrooms dedicated to complex medical device manufacturing.

Our vertically integrated capabilities eliminate dependency on multiple vendors, reducing supply chain risks while providing complete oversight of your device from individual components to finished assemblies.

Supporting Your Innovation Journey at Every Stage

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Research,
Design &
Development

From concept to prototype, we transform innovative ideas into market-ready medical devices through expert engineering, rapid iteration, and material science expertise while optimizing designs for manufacturing and regulatory compliance.

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Quality & Regulatory Management

We provide comprehensive quality systems, regulatory strategy, and continuous improvement methodologies to navigate complex approval pathways while ensuring your medical devices meet stringent global standards throughout their lifecycle.

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Operational
Excellence

Our operational expertise optimizes your product journey through resilient supply chain management, seamless facility transfers, and disciplined program management, ensuring efficient, cost-effective pathways from development to commercialization.

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Cirtec in the News

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June 2, 2025

Smart Catheter Innovations: Navigating Product Development from Concept to Market

Device makers must consider a variety of factors when it comes to fabricating a smart catheter.

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April 24, 2025

Cirtec Medical Expands Costa Rica Operations to Support Increased Industry Demand

Cirtec Medical Expands Costa Rica Operations to Support Increased Industry Demand

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January 15, 2025

The Future of Custom Integrated Circuit Sensing Solutions in Enabling Closed-Loop Drug Delivery Systems

Exploring how custom integrated circuits and sensing technologies are facilitating the development of advanced closed-loop implantable drug delivery systems.

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