Performance Testing for Medical Devices

Performance testing is a crucial phase in the development and regulatory approval process for medical devices. It involves evaluating a device to ensure that it meets predefined standards, functions as intended, and performs safely and reliably under expected conditions. This testing assesses various aspects of the device, including its functionality, reliability, and safety. Functional testing ensures that the device performs its primary functions as intended, while reliability testing verifies its consistency over time and across different environments. Stress and environmental testing determine how the device behaves under extreme conditions, such as high temperatures or humidity. Additionally, biocompatibility testing ensures that materials used in the device are safe for human contact, and regulatory compliance testing confirms that the device meets the requirements of agencies like the FDA or ISO.

Benefits of Performance Testing for Medical Devices

The benefits of performance testing are numerous. It significantly improves patient safety by identifying and mitigating potential risks or failures before the device reaches the market. It also helps secure regulatory approval by demonstrating that the device meets industry standards, expediting the approval process. Moreover, performance testing enhances the reliability of the device, ensuring that it functions consistently in diverse conditions. This, in turn, minimizes the risk of product liability issues, such as lawsuits or recalls. Performance testing also strengthens a device’s competitiveness in the market by showcasing its quality and reliability. It contributes to cost efficiency by identifying issues early in the process, which is much less expensive than handling failures after the device has been released.

Intertek's Solutions for Medical Device Performance Testing

In today’s healthcare market, your team must employ cutting edge technology to challenge the competition. Intertek offers a wide scope of custom performance testing services that help you assess risk and avoid costly field failures. We test well beyond mandatory requirements to determine the effects of certain stresses during your device’s life cycle, helping you to improve efficiencies in your development process and bring your product to market faster.

Battery Safety Testing for Medical Devices

Intertek provides Battery Safety Testing to the Requirements of IEC 62133 for Medical Devices throughout global markets with over 50 years of experience.

Reese's Law – ANSI/UL 4200A-2023

Reese’s Law (ANSI/UL 4200A-2023) has placed safety requirements on consumer products containing button cell or coin batteries in a significant stride towards enhancing child safety.

Accelerated Stress Testing for Medical Devices

Accelerated Stress Testing (AST) from Intertek can save time and lead to quality improvements of your medical devices, helping get you to market faster

Accelerated Reliability Testing

Through Accelerated Reliability Testing Intertek works with you to help uncover design defects or weaknesses that may not have been realized during product design

HALT Testing & HASS Testing

Discover the power of Intertek's Highly Accelerated Life Test (HALT) Testing: a rigorous method designed to push products to their limits, uncovering weaknesses and enhancing reliability.

Benchmark and Comparison Testing

Intertek offers tailor-made Benchmark and Comparison Testing solutions which will help you assess how your products perform against your competition.