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Medical Device Testing Services

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This test confirms that no viable microorganisms are present in or on the sterilized product through carefully controlled incubation and observation.
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Drug samples are stored under accelerated, intermediate, or real-time (long-term) conditions inside stability chambers.
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This analysis checks water for microbial contamination, pH, conductivity, and chemical residues based on ISO and WHO standards.
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The dosage form is placed in a dissolution vessel containing simulated gastric or intestinal fluid, and agitated using a USP Dissolution Apparatus
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A fabric sample is securely clamped in a hydrostatic head tester, and water pressure is gradually increased on one side of the fabric until leakage is observed.
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Bioburden testing estimates the number of viable microorganisms present on a product. This helps design and validate the sterilization process.
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Samples of drug products or raw materials are prepared and subjected to analytical techniques to detect, quantify, and classify residual solvents.
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This test measures the resistance of insulating materials under electrical stress, ensuring that the device’s insulation effectively isolates live circuits.
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This mapping study records environmental conditions over time to identify hot/cold zones and verify uniformity.
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Samples are digested or treated with appropriate acids/solvents and analyzed using advanced instrumentation to determine heavy metal concentrations with high sensitivity and accuracy.
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This evaluation subjects the device to a range of electromagnetic environments to assess its ability to resist interference.
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The dosage form is placed in a disintegration test apparatus containing a prescribed liquid (typically water, simulated gastric, or intestinal fluid) and maintained at body temperature (37°C ± 2°C).
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Prepared samples are measured using a calibrated pH meter, with test conditions depending on the specific dosage form.
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Standardized specimens are cut and mounted in a Universal Testing Machine (UTM), which applies a gradually increasing tensile load.
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Material specimens are subjected to controlled flexing cycles using a flexometer under defined environmental conditions.
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Comprehensive Test Matrix Across Key Sectors with Applicable Standards