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Medical Device Manufacturing

From concept to certified manufacturing

Certified Manufacturing

Your product has completed development and is ready for serial production with uncompromising quality and economic efficiency. Serial production is more than just fabrication. It demands reliable processes, precise testing and continuous improvement with seamless documentation. Ergo-Tec is the partner you can rely on today and for the long run.

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Reliability every step of the way – from procurement to serial production

At Ergo-Tec, the path to serial production of your product is a smooth one, free of quality issues or delivery delays. Our experience, along with well-defined SOPs and robust production processes, prevents costly correction loops and accelerates your time to market.
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2. Maximum product quality – from the get-go

Every product must be flawless without compromise. Tested materials, strict quality controls, and precision measuring equipment ensure this. Each and every component is tested and documented pursuant to explicitly defined specifications. This attention to detail secures the fulfillment of all your requirements.
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Seamless traceability for full control

You must be able to evince the origin of components and their technical compliance at all times during the development process. Our ERP system with 2D scanner guarantees complete traceability from material procurement to final assembly. This enables you to further minimize production risks while easily meeting all regulatory requirements.
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Reliable supply chains – easing your burden

While materials shortages and supplier unreliability may jeopardize your production, Ergo-Tec has relied on a stable network of long-standing, audited partners for decades, who are familiar with our standards and deliver reliably. You benefit from plannable production – without any unseeming surprises.

With Ergo-Tec, you reduce risks and efficiently bring your product into serial production, saving you time, money, and market share. At exceptional quality and on-time.

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OEM & contract manufacturing

OEM Manufacturing

You have developed a medical device but lack your own production facilities. You are a start-up company looking for a reliable production partner. You need an additional medical device or component to complete your product. Your production capacities are overstretched. Or you would like to reduce the complexity and variants in your production?

No problem. We have your back!
Ergo-Tec is your reliable outsourcing partner.

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You develop. We manufacture.

We execute the full assembly of your device according to your specifications – including all inspections and functional tests. With our expertise, we confirm that your product works perfectly and meets all the required standards and certifications. You can be certain each device is produced exactly as you need it. Seamless traceability, stable supply chains, and decades of experience reinforce that your product is manufactured to the quality you expect.
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Manufacturing without your own facilities? It`s possible with Ergo-Tec.

You need a reliable manufacturing partner. We would like to be that partner. Let's talk about how we can efficiently elevate production for you.
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Medical device assembly & supply

Assembly-supply

Perfect assembly, on-time delivery

Each component and assembly is crucial to the quality and performance of your product. We ensure that all components are perfectly assembled, neatly wired and reliably delivered. You are freed to concentrate on your core business.

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Assembly

We assemble components into exceptional modules. Thanks to standardized processes and modern manufacturing technology, we confirm that all components are precisely and compliantly calibrated. Our quality control protocols ensure each unit meets your requirements exactly.
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Wiring

Precise wiring powers performance and guarantees the safety of your product. Our technicians and engineers verify all electrical connections are calibrated precisely and comprehensively, from customized cable assembly to integration into the end device. Protocols for circumspectly designing cable routing, impeccably clean workmanship and factory standards result in long-lasting solutions. These solutions work reliably and ease product maintenance.
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Delivery

Your product or assemblies should arrive on time without issue. We coordinate both national and international shipping and assure they arrive at the correct destination, safely, and on time. Let's talk about your requirements!
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Customized solutions

Quality Inspection & Testing

Testing

Quality is not a matter of chance. We make certain of it. We apply modern testing and calibrated measurement equipment to record your product at every stage of production: Dimensions, tolerances, and functions applied from incoming goods through every production step to outgoing goods; everything is checked, documented and then released. Your benefit is medical technology that works reliably and meets all requirements.

Shipping & logistics

Logistic

Whether to the USA, Europe or Asia, we deliver your products to your desired destination. Working with proven logistics partners, we ensure customized packaging and secure, timely shipping. In cooperation with specialized packaging companies, we develop solutions tailored to your product – safe from damage while remaining cost-efficient. Your medical technology arrives worldwide – reliable, safe, and ready for use.

UDI & Component Traceability

Traceability

We can trace and analyze the entire production chain at any time. Where does each individual component come from? When was it made? Our ERP system with a 2D scanner assists by tracing all components back to their raw constituent materials. This is how we ensure not only seamless documentation and transparency, but also more security, faster troubleshooting and successful audits and approvals.

Alexander Dürsch

Your contact

Alexander Dürsch
Owner and CEO

+49 9104 82969-0

mydevice@ergo-tec.com

Contact Form

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