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Ensuring precision, compliance, and efficiency in medical device manufacturing

Medical device manufacturers face unprecedented complexity. Personalized healthcare, increasingly strict compliance requirements, and accelerating time-to-market demands necessitate innovation without compromising quality. To thrive in this highly regulated environment, you need tools that integrate seamlessly with your existing manufacturing systems. With Andea’s solutions, you achieve the precision, traceability, and efficiency needed to gain a competitive advantage.

Medtech Connections

Achieve manufacturing excellence

Meeting your needs is our priority. Be empowered to respond swiftly and accurately to defects, enforce consistent production standards, and manage complex regulatory requirements like Electronic Device History Records (eDHR). Gain tools to accelerate new product introductions, synchronize material flows, and drive continuous improvement across your operations.

CoorsTek started working with Andea after they were highly recommended due to their extensive experience in both the Apriso platform and manufacturing software in general. It was clear very early on that this recommendation was warranted as Andea exceeded our expectations both in what they produced and how they did it. We, as a combined team, successfully completed our implementation under budget with over 300% of the planned scope

Brian Frimel
Director Manufacturing IT, CoorsTek
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Achieving Digital Transformation In Medical Device Manufacturing Webinar Short

Why MedTech companies need medical device manufacturing software to achieve digital traceability

Watch our expert James Delnick answering a participant’s question in this webinar teaser. Visit the webinar’s web page for the whole session.

Visit the webinar

What you can expect

We bring unmatched expertise in helping MedTech companies that strive to balance quality standards and compliance requirements while meeting aggressive timelines. Our DELMIA solutions integrate seamlessly with your manufacturing processes, ensuring real-time data access, digital traceability, and optimized production operations.

DELMIA offers proven capabilities that redefine operational excellence for medical device manufacturers. 

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You will experience

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Improved on-time delivery

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Greater throughput

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Reduced lead times

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Lower premium freight costs

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Increased inventory accuracy

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Reduced global inventory

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Decreased line-side inventory

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Faster time-to-market

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Shorter order fulfillment times

How you will transform

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Quality standards

Reduce design flaws, streamline production, and eliminate product recalls with robust quality control tools. Implement preventive measures to ensure consistent product quality and reduce costly disruptions.

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Regulatory compliance

Meet the mandatory industry regulations, including FDA compliance, ISO standards, EU MDR, and other strict regulatory requirements. Leverage digital traceability to provide rapid and accurate responses to audits or defects.

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Digital traceability

Gain comprehensive insight into material and process genealogy. Ensure full traceability across the production lifecycle, enabling seamless regulatory reporting and accurate root cause analysis.

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Production optimization

Optimize production processes by coordinating orders, resources, and maintenance activities to maximize shop-floor efficiency. With real-time data, improve operator satisfaction and productivity.

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Innovative technology

Plan and streamline your manufacturing operations before production even starts. DELMIA technology enables effective planning, scheduling, and execution of your manufacturing processes. Use predictive insights and enhanced visibility to minimize delays and nonconformances, all while accelerating innovation cycles.

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Faster time to market

Optimize every step of your manufacturing process to accelerate production, maximize resources, and reduce lead times for faster time to market. Synchronize workflows, reduce bottlenecks, and achieve sustainable improvements in efficiency to deliver products faster.

How you will benefit

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Efficiency

Streamline production cycles to optimize resources and reduce costs with real-time optimization tools.

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Quality

Ensure consistent, high-quality outcomes with advanced statistical process control and robust quality metrics.

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Traceability

Achieve end-to-end visibility across your supply chain, production processes, and quality control.

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Compliance

Seamlessly meet regulatory requirements with tools designed to enforce production control and ensure eDHR accuracy.

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Visibility

Gain instant access to critical data and vital insights for informed decision-making and operational transparency.

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Productivity

Boost throughput and reduce lead times to optimize resources and drive continuous improvement initiatives.

Trusted by leading MedTech companies

We have a proven track record of driving transformative results for over 80 manufacturers across 260 sites. Global MedTech leaders, like Straumann and CoorsTek, chose us to implement DELMIA solutions, driving streamlined operations, enhanced compliance, and significant cost savings.


Imagine responding to an FDA inquiry or addressing a production flaw in real time. We provide the tools you need to ensure rapid containment, accurate impact assessment, and seamless adjustments.

How DELMIA drives results

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Ready to lead the future of MedTech?

Contact us today to transform your operations and gain a lasting competitive edge.

Contact us
Publication:
Wednesday, January 8, 2025
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