Medical Device Manufacturing
Medical Device Test Systems Built to Evolve
From hearing aids to surgical robotics, medical devices demand absolute precision, repeatability, and compliance. Testeract delivers modular, vendor-neutral ATE platforms that reduce test cycle times, meet global regulatory standards, and scale with new product generations.
Why Medical Device Manufacturing Test Systems Fail Forward
Industry challanges
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Strict regulatory requirements (FDA, ISO 13485, IEC 60601) demand traceable, validated test results.
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Manual test processes slow throughput and increase risk of human error.
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Variant management across device models and revisions complicates test workflows.
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High cost of downtime — even small disruptions risk delaying production and compliance.
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Obsolescence pressure threatens long-term sustainability of test platforms.
Our Approach
Full System Integration
Medical test systems must handle diverse DUTs while meeting compliance and throughput targets. Testeract integrates PXI, LXI, FPGA, and custom I/O into scalable platforms built for accuracy and efficiency.
Key Medical Benefits:
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Support for electrical, functional, and simulation-based test in one system
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Compliance-ready architectures validated for FDA/ISO audits
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Variant coverage across multiple devices without costly reinvention
Software Framework & Automation Tools
Our TestPoint™ HAL-driven framework separates test logic from hardware, enabling updates without disrupting validated processes. This reduces revalidation cost and risk.
Key Medical Benefits:
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HAL abstraction ensures continuity with mixed vendor instruments
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Automated reporting with full traceability for compliance
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Support for LabVIEW, TestStand, Python, and MATLAB ecosystems
Design Engineering & Lifecycle Support
We provide not just test platforms, but long-term sustainment strategies to keep medical programs compliant and running.
Key Medical Benefits:
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Obsolescence management and refresh planning to extend system life
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Documentation, training, and operational ownership transfer
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Lifecycle support for evolving FDA/ISO standards
Applications
Proven Across Medical Device Programs
“A test system isn’t just a project expense — it’s a program enabler, if done right.”