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Our exacting team is skilled in taking projects through the entire

process for critical FDA compliant medical components

and devices created for the OEM market.

From collaborating on your design to manufacturing,

painting, imprinting unique identifier numbers (UID), testing,

assembling, and packaging, we offer a full range of services to meet your every need.

 

Altek conforms to the strictest standards for US and international compliance. We are ISO 13485 certified and meet or exceed the standards set for quality and regulatory requirements, including offers REACH and RoHS compliant manufacturing. Our rigorous supply chain management utilizes BOMCheck as a tool to manage raw materials and supply chain partners for regulatory service.

RESULTS FOR THE

MEDICAL COMMUNITY

You can depend on Altek’s Medical Manufacturing Process Validation to provide consistent process results and product reliability to help you bring your medical products to market quickly and safely.

MEDICAL EQUIPMENT MANUFACTURING

Product Examples

  • Ultrasound Equipment

  • Heart Defibrillators​

  • Surgical Lasers

  • Kidney Dialysis Components

  • Diagnostic Optics Manufacturing

  • High Quality Medical Injectors (needle and non-invasive)

  • Molded Enclosures

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Altek Medical offers top-of-the-line custom injection molded manufacturing for medical devices and components for integration into a wide array of medical equipment such as ultrasound machines, EKG machines, and cardiac defibrillators. 

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AUTOMATED VISUAL INSPECTION SYSTEMS

Reliability in Testing

Altek’s Custom Automated Visual Inspection is able to detect product flaws and weaknesses that are invisible to the naked eye, and can be programmed to inspect for thousands of product features.

PROCESS VALIDATION

Medical Component Verification

Process Validation is required for the manufacture of 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.

CONTRACT MEDICAL ASSEMBLY

In-House and Secondary Services

Altek’s Contract Assembly services help guide the entire design process. We perform a rigorous Design for Manufacturing & Assembly (DFMA) to ensure all components are optimized for medical assemblies.

 

Handle all your manufacturing, assembly and testing needs with Altek’s in-house manufacturing and value-added Secondary Services.

ALTEK’S MEDICAL DEVICE MANUFACTURING INCLUDES