Empirical Technologies Corp. has extensive experience in medical device testing; our experienced team of experts works tirelessly to present you with reports that can meet global regulatory guidelines.

Fatigue testing is a vital part of medical device testing that aims to determine material and specimen behavior during cycle loading. Medical device testing is complex and highly regulated due to the potential risks associated with these products’ applications; in turn, it is vital that fatigue testing services are performed by a company that understands and adheres to such details as sample size, stress levels, and other protocols.

Medical Device Fatigue Testing

Medical devices are the most commonly tested device at Empirical Technologies Corp. As a result, we have a clear understanding of the rigors associated with properly carrying out fatigue testing services. We are an accredited mechanical testing laboratory, specializing in medical devices and our team is well-versed in the process of creating test plans. Our complete service package includes an unparalleled technical report that can be submitted to regulatory bodies, such as the FDA, in order to meet stringent industry requirements. Medical device fatigue testing starts by testing a sample group with high peak stress, or strain; at this point, failure will occur at a low number of cycles. From here, samples will be tested at progressively lower stress levels until a significant number of samples do not fail in a pre-determined number of cycles. The fatigue threshold is determined by defining the highest stress at which samples do not fail. Empirical Technologies Corp. works to develop an appropriate sample size for your device based on factors like the number of tests needed in order to achieve statistical confidence, the cost of test specimens, the standard deviation, and the desired statistical significance. With 24-hour operations and an experienced team of mechanical engineers, we have the conceptual knowledge and practical experience to bring high-quality fatigue testing to fruition for your medical device.

Why Empirical Technologies Corp?

Our long-standing experience in this industry allows us to respond to the fast-paced product development environment of medical devices with relative ease. Empirical has spent more than two decades cultivating an unsurpassed reputation in the medical device testing industry, and we work to maintain that reputation with each project. Our staff acts as an extension of your team, so you can rest assured that our practices are customized and high quality at every step in the process. Having operated in this industry for so long, we are familiar with FDA requirements, so we position you with all of the necessary documentation as you prepare to submit your device for review.

The importance of experience can hardly be overstated when it comes to medical device testing in general, but especially when it comes to fatigue testing services. To capitalize on the expertise of our team, contact us today to request a quote.