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// Research, Design,
   Development

Research, Design
& Development

LEADING
INNOVATION

Transforming innovative medical device concepts into market-ready solutions through expert engineering.

OVERVIEW

Comprehensive Research, Design & Development Services

Cirtec provides end-to-end research, design, and development services for Class II and III medical devices, specializing in active implants, neurovascular, and minimally invasive technologies.

Our expertise in system integration, miniaturization, and regulatory compliance ensures high-performance, manufacturable solutions. With in-house prototyping, advanced engineering, and a structured development process, we accelerate time to market while maintaining quality,

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precise fabrication

Innovation Offerings

RESEARCH, DESIGN, DEVELOPMENT SERVICES
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EXPERTISE

Rapid Prototyping

Accelerate your development cycle with our vertically integrated prototyping capabilities that deliver functional, production-ready test models.

In-house 3D printing and machining creates complex geometries with precision tolerances within days.

Prototype using actual production materials including silicone, polymers, and multi-lumen extrusions for realistic testing.

Seamless design iterations capture challenges early, reducing development time and preventing costly modifications.

Production-focused approach ensures smooth transition from prototype to manufacturing with minimal design changes.

In-House Material Science

Our materials expertise enables selection of biocompatible polymers, metals, and composites optimized for your device's performance, durability, and regulatory requirements.

Material testing verifies properties under physiological conditions to predict long-term device performance.

Biocompatibility assessment identifies materials that minimize adverse reactions while maximizing effectiveness.

Processing techniques optimize material properties for specific device requirements and functional needs.

Collaboration between scientists and engineers ensures materials align with design specifications.

Custom Software Development

Our full-stack software team creates embedded firmware, cloud solutions, and user interfaces tailored to enhance your medical device's functionality and user experience.

Firmware delivers reliable embedded systems that optimize power management for portable devices.

Mobile and desktop applications provide intuitive interfaces to control device functions.

Cloud integration enables secure data collection and remote monitoring for improved outcomes.

Compliant software development follows IEC 62304 standards to streamline validation processes.

Design for Manufacturing

Our engineering team integrates manufacturing considerations from the earliest design stages to optimize your product for production efficiency and cost-effectiveness.

Material and component decisions are guided by manufacturability, reducing complexity and time-to-market.

Design reviews identify challenges before they become costly production problems or regulatory delays.

Process Development

We create robust, efficient manufacturing processes tailored to your medical device requirements, ensuring scalability from prototype to commercial production.

Comprehensive process risk assessment identifies critical control points to maintain quality throughout production.

Validation protocols establish parameters that consistently deliver components meeting design specifications.

Statistical process control methodologies optimize yield while minimizing variation in critical device characteristics.

Continuous improvement evolves manufacturing processes to enhance efficiency and reduce costs.

Packaging Design

We develop custom packaging solutions that protect device integrity, maintain sterility, and enhance usability while meeting rigorous regulatory requirements.

Sterile barriers engineered to ISO 11607 standards ensure product safety through clinical use.

Materials optimize protection during shipping and handling while minimizing environmental impact.

Human factors testing evaluates packaging for intuitive opening to minimize procedural errors.

Validation testing simulates real-world conditions to verify packaging throughout the product lifecycle.

Expertise
RESEARCH, DESIGN & DEVELOPMENT

Designing Tomorrow's
Medical Innovations Today

  • Cross-functional teams reduce iterations and accelerate timelines
  • Rapid prototyping validates designs with production materials
  • Smooth transition from development to manufacturing
  • Our quality management system complies with FDA and ISO, ensuring compliance at every stage.

With over 35 years of experience and more than 800 completed projects including 20 PMA/IDE-approved devices, Cirtec transforms concepts into commercial realities.

Our vertically integrated approach combines cutting-edge technology with deep regulatory knowledge, allowing us to compress development timelines while ensuring manufacturability and compliance from the earliest design phases.

Supporting Your Journey at Every Stage

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Manufacturing Services

Our ISO-certified facilities deliver precision manufacturing for complex medical devices, integrating cleanroom assembly, specialized secondary operations, and comprehensive sterilization management to ensure quality 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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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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November 13, 2024

The Medical Device Handbook – November 2024 Edition

Industry recognition of Cirtec's technical expertise in advanced nitinol processing for medical device manufacturing.

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