In modern healthcare, precision in drug delivery is no longer a luxury; it’s a necessity. Devices like infusion pumps and syringe pumps are designed to deliver life-saving medications at controlled rates. Whether it’s insulin for diabetic care, chemotherapy in oncology, or pain management in intensive care units, even a slight deviation in flow rate or dosage can lead to serious complications.
Given the risks, regulatory bodies such as the CDSCO, IEC, and ISO have established stringent testing and compliance protocols. For manufacturers, ensuring that these devices meet performance, safety, and quality standards is essential, not just for regulatory approval but also for protecting patient outcomes.
At Astute Labs, we specialize in testing these critical devices across all key parameters, offering reliable results backed by our NABL, BIS & CDSCO-accredited facility and decades of domain expertise.
Why Drug Delivery Device Testing Is Essential
Infusion and syringe pumps are used across hospitals, homecare, and ambulatory settings. Their function may seem simple: to deliver medication at a consistent flow. However, the execution must withstand varying patient conditions, software demands, and environmental changes.
A minor malfunction, like an undetected occlusion or fluctuating flow, can cause underdose, overdose, or complete therapy failure. That’s why regulatory guidelines such as IEC 60601-2-24 (specifically for infusion pumps), stress functional performance, alarm systems, and electromagnetic compatibility (EMC).
Without comprehensive testing, these devices remain a liability.
What Goes Into Our Testing Approach
At Astute Labs, testing goes beyond checklists. We begin by simulating real clinical scenarios, ensuring pumps deliver fluids accurately over long durations, under stress conditions, and across diverse temperature and pressure environments.
We assess key factors such as:
- Flow rate accuracy: Can the pump maintain a consistent dose over hours?
- Alarm verification: Does the device raise alarms in occlusion, battery failure, or air-in-line scenarios?
- User interface safety: Are settings, dose entry, and controls intuitive and protected against accidental changes?
- EMI/EMC testing: Does the device function without disruption from nearby MRI machines, mobile phones, or other electronic equipment?
All tests are executed in line with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-24, international benchmarks for electrical safety, electromagnetic compatibility, and infusion device performance.
We also calibrate flow analyzers, pressure sensors, and electrical meters in our Biomedical calibration lab to ensure data precision and regulatory traceability.
Traceability and Documentation You Can Rely On
One of the most overlooked elements in medical device testing is documentation. At Astute Labs, each device undergoes serial-number-based tracking. Calibration logs, raw data, pass/fail criteria, and deviation reports are all stored and formatted as per global regulatory expectations whether you’re filing for CDSCO (Form MD-40), CE, or FDA approvals.
This level of traceability is what makes the difference during audits, product recalls, or future product iterations.
Why Choose Astute Labs for Infusion and Syringe Pump Testing
With over 15 years of experience in Medical device testing, we’ve helped startups and multinationals bring safe, compliant products to market faster. Our integrated testing ecosystem includes EMI/EMC labs, equipment calibration, and regulatory support under one roof.
We’re accredited by NABL and recognized by CDSCO, BIS, and QAI, which lends credibility to our reports across India and beyond.
Want to learn what sets us apart? Read Why Astute Labs Is the Trusted Choice for Medical Device Testing.
Testing That Builds Confidence
When patient safety hinges on milliliters per hour, there’s no room for error. Infusion and syringe pumps must pass rigorous, real-world testing before they can earn the trust of clinicians and regulators.
At Astute Labs, we’re here to help you achieve that trust through reliable results, complete traceability, and full compliance support. Book a consultation with our testing team
