In-line Testing
Real-time Quality Assurance
In-line testing
What is IT and why is it critical?
In-line Testing is a critical quality control process performed during the manufacturing of medical devices. Unlike end-of-line inspection, it enables real-time or near-real-time validation of product quality and performance. By detecting deviations early, it supports consistent product quality, minimizes rework, and strengthens regulatory compliance. It is especially valuable for high-precision devices like infusion therapy pumps and IV sets where reliability and patient safety are non-negotiable.
Key Benefits
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Early detection of deviations
Identifies surface, dimensional, or functional issues before final assembly, minimizing risk. -
Compliance and traceability
All tests are conducted in alignment with ISO 13485 and FDA 21 CFR Part 820, and results are logged in the Device History Record (DHR). -
Cost-effective process control
Reduces scrap and rework, lowering cost of poor quality (COPQ) and increasing production efficiency. -
Support for continuous improvement
Real-time data enables faster feedback loops, improving manufacturing control and decision-making. -
Patient safety and audit readiness
Ensures devices perform as intended in critical applications, reinforcing safety and supporting regulatory inspections.
Key Factors
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Automated test integration
Testing should be embedded in the manufacturing line with vision systems, PLCs, or custom-built stations. -
Data management systems
Capability to feed test data into MES or SPC dashboards for full traceability and statistical control. -
Broad test capabilities
A reliable partner should offer dimensional, visual, leak, electrical, and pressure testing as applicable to each device. -
Integrated Quality Control
In-process and final inspections to verify compliance with specifications. -
Validation and calibration procedures
Equipment must be validated and routinely calibrated, with documentation to support regulatory compliance.
Certifications
RexMed's Competitive Edge
RexMed delivers end-to-end in-line testing solutions as part of its integrated manufacturing workflow. From automated visual inspection to real-time flow and electrical testing, each station is designed to meet the performance and compliance expectations of OEMs and healthcare customers.
Our team ensures seamless integration into production lines while providing guidance on testing best practices and user training. With experience in infusion devices, IV sets, and diagnostic components, RexMed ensures consistent results that meet international standards.
Ensure every device meets quality standard.
Explore our In-line Testing capabilities today.
FAQ
Are the in-line test stations calibrated?
Yes. All test equipment undergoes regular calibration and validation procedures as part of our quality system.
Can the testing data integrate with my MES system?
Yes. Our systems can be configured to feed data directly into your MES or SPC dashboards.
Is RexMed’s testing process traceable?
Yes. All test results are recorded in the Device History Record (DHR) and aligned with ISO 13485 standards.
What testing methods are included?
Visual inspection, dimensional measurement, leak detection, electrical validation, pressure and flow testing.
What types of devices are tested with RexMed’s in-line systems?
Infusion pumps, IV sets, catheters, diagnostic devices, endoscopes, and more.