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QUALITY AND REGULATORY

High Performance. High Quality.

Quality is core to who we are and what we do. We strive to provide products that are flawless in their intended use and “right the first time,” raising the bar on expectations.

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ENSURING QUALITY AND COMPLIANCE ACROSS EVERY PROJECT

Our goal is to manufacture high-quality products that deliver superior performance, consistency, safety, and value.

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Quality Management & Regulatory Compliance

Our continuously improved Quality Management System (QMS) ensures compliance with customer and regulatory standards, supporting the reliable supply of high-quality products. Certified to ISO 13485:2016, we focus on risk management and meeting all relevant regulatory requirements.

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Expert Validation & Process Engineering

Our experienced validation and process engineering team excels in areas like DFM, dFMEA, pFMEA, IQ, OQ, and PQ, offering tailored validation solutions for each project. We remain agile in adapting to specific client and product requirements while providing robust quality assurance tools like CPK, SPC, IPC, and material spectrographic analysis.

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Controlled Manufacturing Environments & Clean Room Capabilities

White room manufacturing takes place in a meticulously controlled, environmentally tested environment designed to meet the most stringent cleanliness and safety standards. This process ensures that every product is developed under optimal conditions, minimizing contamination risks and maintaining consistent quality. Our commitment to such precision guarantees that all materials and components are handled in an atmosphere regulated for temperature, humidity, and air ensuring the appropriate level of controls.

Other Capabilities

SET YOUR POSSIBILITIES INTO MOTION

Experience the fresh thinking, engineering edge, and customer focus that helps you advance.

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