Sample Stability Testing for IVD Devices
In vitro diagnostic (IVD) devices are critical tools used in healthcare settings to diagnose diseases and monitor patient health. The reliability of these tests is paramount, as any deviation from expected performance could lead to incorrect diagnoses or ineffective treatments. Sample stability testing ensures that the reagents, calibrators, controls, and other components of IVD devices remain stable under various environmental conditions over their shelf life.
Stability testing involves exposing samples to a range of stressors such as temperature, humidity, light, and storage duration. The goal is to assess whether changes in performance are within acceptable limits defined by regulatory standards like ISO 17895:2016 for IVD devices. This process helps manufacturers ensure that their products meet stringent quality requirements before they reach the market.
Our laboratory specializes in providing comprehensive sample stability testing services tailored to the unique needs of IVD device developers and manufacturers. By simulating real-world conditions, we help clients identify potential issues early on so they can refine their formulations or processes accordingly. This proactive approach not only enhances product quality but also reduces costs associated with post-market recalls.
The testing procedure begins by selecting appropriate stability challenges based on the intended use of the device and regulatory expectations. For instance, if an IVD test is designed for use in tropical climates where high temperatures are common, then higher temperature stressors would be included in the protocol. Similarly, humidity levels could reflect conditions found in certain storage facilities.
Once the stressors have been identified, samples from each batch of production must undergo rigorous testing according to predefined protocols. These may include accelerated aging tests at elevated temperatures and humidity levels or long-term exposure experiments conducted under normal shipping conditions. Throughout this process, critical parameters such as accuracy, precision, linearity, and stability are continuously monitored.
After completing all required stability trials, detailed reports summarizing results are generated for submission to regulatory authorities. These documents provide evidence demonstrating compliance with relevant standards and guidelines. They also serve as valuable resources during product development iterations or when responding to any queries from health agencies.
By leveraging advanced analytical techniques and state-of-the-art equipment, our team ensures accurate measurements and reliable conclusions about sample stability. Our expertise spans various types of IVD devices including point-of-care tests (POCT), molecular diagnostics, immunoassays, and more.
Benefits
- Ensures consistent performance of IVD devices across all batches
- Aids in identifying potential quality issues early in development
- Enhances product reliability leading to better patient outcomes
- Facilitates compliance with regulatory guidelines and standards
- Saves costs by minimizing post-market recalls due to ineffective products
Environmental and Sustainability Contributions
- By ensuring product quality through thorough testing, we contribute to reducing the likelihood of incorrect diagnoses and subsequent unnecessary treatments.
- The use of advanced technologies in our laboratory helps minimize waste generation during sample preparation and analysis.
- We promote sustainable practices by supporting manufacturers who aim to improve their products’ shelf life and reduce packaging material usage.
Eurolab Advantages
At Eurolab, our commitment to excellence extends beyond just providing high-quality testing services. We offer several advantages that make us a preferred choice for IVD device manufacturers:
- A team of highly qualified scientists with extensive experience in medical device testing.
- Access to cutting-edge equipment capable of simulating real-world conditions accurately.
- Comprehensive report generation tailored specifically for your product and regulatory requirements.
- Proactive approach towards identifying potential problems early, thus saving time and resources.
