Consistent product quality and performance are non-negotiables.

With our Critical Parameter Management (CPM) approach, we oversee critical parameters throughout the manufacturing lifecycle. From identifying Critical Functional Requirements (CFRs) to implementing robust manufacturing process controls on the Critical-to-Function (CTF) characteristics, we leave no stone unturned in ensuring the reliability and effectiveness of your medical device.

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Critical Parameter Management

We utilize a systems engineering approach, starting with identifying CFRs that directly impact device safety and performance. We then identify and link CTF attributes from a top-down perspective. The overall objective is to implement robust manufacturing process controls that ensure consistency across various levels, including system, subsystem, component, and manufacturing process.

At Meddux, we have developed a comprehensive approach and concise documentation that trace these high-level requirements to ongoing quality controls in manufacturing. This documentation is a lifecycle management tool, delineating requirements for component inspection, process validation, test method validation, and component qualification throughout the manufacturing process and supply chain. 

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    Learn More about Meddux’s CPM Approach

    Maximizing Efficiency and Quality: The Meddux Approach to Design for Manufacturability and Critical Parameter Management

    More About Meddux

    At Meddux, our mission is clear: to be your long-term partner for designing, developing, and manufacturing complex medical devices. With world-class engineers, technicians, and designers at your service, we’re here to guide you through the product lifecycle.

    Testimonials

    “Working with Meddux is truly working with the best people in the industry. From project management, to engineering, manufacturing, and quality, they are skilled, knowledgeable, and responsive. When design, validation, or manufacturing challenges occur, Meddux partners with us to find the best, most efficient and creative solutions for moving our project forward.”

    VP Quality & Regulatory
    RF Electrosurgery Startup, USA

    “We really appreciate the fantastic technical expertise and responsiveness of the Meddux team. As an early startup, this support has been so valuable in helping us drive our first product through FDA submission and early manufacturing.”

    Co-Founder
    Minimally Invasive Surgery Startup, USA

    “Meddux is great to work with. Speedy responses, excellent communication. We are a new customer and Meddux was able to capture what was needed for our product.”

    VP
    Surgical Products OEM, USA

    “Meddux are a responsive team with high technical acumen and product development capabilities. They are fast, focused and stay close to be agile and adapt quickly to changing conditions.”

    CTO
    Interventional Startup, Ireland

    “Great turn around and results on the trial build. I look forward to working with Meddux on future product development and clinical builds.”

    Program Director
    Minimally Invasive Surgery Startup, USA

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