Quality Testing

Quality Plan

We develop comprehensive quality plans tailored to your product and regulatory pathway, ensuring every step — from design to delivery — is governed by controlled processes, risk management, and compliance with ISO 13485 and FDA QSR standards.

Bench Testing

Our bench testing services replicate real-world clinical scenarios to evaluate mechanical, electrical, and functional performance. We help you identify potential failure modes early and ensure design robustness prior to clinical deployment.

Physico-Chemical Testing of Biomaterials and Drug Delivery Systems

We characterize the physical and chemical properties of biomaterials and drug formulations using validated analytical techniques. From stability and degradation to drug release kinetics, our testing ensures biocompatibility, safety, and regulatory readiness.

Visual Inspection

We conduct systematic visual inspections under controlled lighting and magnification to detect cosmetic and structural defects. This first line of quality control ensures compliance with appearance standards and customer specifications.

Dimensional Analysis

Precision matters in medtech. Our dimensional analysis services verify part geometries against design specifications using calibrated tools and metrology equipment, ensuring fit, function, and manufacturability.

Defect Analysis

Our team investigates material and process-related defects using root cause analysis, microscopy, and failure analysis methods. This enables continuous improvement, reduces scrap rates, and supports corrective actions.

Packaging Integrity Testing

We perform rigorous packaging integrity tests including seal strength, burst, dye penetration, and microbial barrier assessments. These ensure sterility, safety, and compliance with ISO 11607 and FDA packaging guidelines.

Simulation

Using advanced modeling and simulation tools, we predict device behavior under various stressors and operating conditions. This accelerates iteration cycles, optimizes design performance, and reduces the need for costly physical testing.