A B O U T  U S

ISO 13485 -Certified CDMO Supporting All Stages of Product Commercialization

We are a contract development and manufacturing company (CDMO) supporting all stages of product commercialization under ISO 13485 certification. With over 35 years of experience in regulated production, we specialize in wearable medical sensors and flexible electrodes.

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S E R V I C E S

From Idea to Production – Reliably

R&D and Prototyping

We are able to turn your concepts into working prototypes within weeks and seamlessly scale them for mass production. We offer complete R&D support, from feasibility and prototyping to commercialization, backed by full vertical manufacturing. Whether in medical, diagnostics, IoT, or flexible electronics, our expertise transforms your product from vision to reality.

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Production

Screentec delivers end-to-end production support, from prototypes to full-scale manufacturing. Our vertically integrated processes ensure speed, flexibility, and compliance with ISO 13485, FDA 21 CFR Part 820, and IEC 60601 standards. We optimize designs, reduce costs, and scale from prototypes to hundreds of thousands of units — always with world-class expertise in regulated manufacturing.

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Quality Assurance & Regulatory Affairs

Screentec’s ISO 13485 and ISO 9001 certifications support our growth as a contract manufacturer of medical devices and components. Our quality management system complies with EU MDR (2017/745), IVDR (2017/746), FDA 21 CFR Part 820, and other applicable regulations, strengthening our risk management and commitment to continuous improvement and exceptional service.

QUICK LINKS:

ISO 13485 Quality Certificate
ISO 9001 Quality Certificate

S E G M E N T S

From Idea to Production – Reliably

We deliver design-to-production services under one roof – from concept design and manufacturability to material sourcing, process engineering, and regulatory support. Whether in medical, diagnostics, IoT, or flexible electronics, our expertise transforms your product from vision to reality.

Medical Electrodes

Screentec designs and manufactures high-quality wearable ECG patches, from passive electrodes to fully integrated solutions with sensors and electronics. We optimize signal quality, comfort, and sustainability, and can integrate temperature, motion, and heart rate variability sensing to support advanced data interpretation. With over 10 years of expertise in printed electronics and wearable biosensors, we deliver custom electrodes for both diagnostic and therapeutic applications.

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Diagnostics

With over 35 years of experience in printed electronics and material conversion, Screentec helps customers turn ideas and prototypes into scalable diagnostic and microfluidic devices. Our diagnostics team specializes in developing and manufacturing consistent, high-quality electrochemical sensors, Point-of-Care platforms, and in vitro diagnostic tools through expert process development and rigorous quality control.

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Industrial

Since the 1990s, Screentec has manufactured durable, high-performance user interfaces for medical, marine, industrial, automotive, and ATEX applications. We offer everything from membrane switches and technical overlays to hybrid assemblies and large-area printed sensors — built for extreme environments and demanding applications with stylish, functional design.

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N e w s  &  B L O G

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