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MEDICAL EQUIPMENT MANUFACTURING​

 

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Examples:

  • Ultrasound Equipment

  • Heart Defibrillators​

  • Surgical Lasers

  • Kidney Dialysis Components

  • Diagnostic Optics Manufacturing

  • High Quality Medical Injectors 

  • Molded Enclosures

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PROCESS VALIDATION

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Medical Component Verification

A variety of Process Validation is required to manufacture most life-critical FDA medical components and devices. Altek’s Process Validation ensures our medical manufacturing processes are highly repeatable and meet the control criteria laid out by the FDA.

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ALTEK’S MEDICAL DEVICE MANUFACTURING INCLUDES:​

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Altek is certified to the ISO 13485 standard, meeting both U.S. and International requirements. We maintain a robust and transparent supply chain by leveraging BOMCheck to manage raw materials and collaborate with supply chain partners for effective regulatory compliance.

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Our experienced team specializes in guiding projects from concept to completion, delivering FDA-compliant, mission-critical medical components and devices tailored for the OEM market.​​

© 2000 - 2025 Altek, Inc. All Rights Reserved. 

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