Empirical Technologies is an accredited mechanical testing laboratory leading the way in medical device testing. Our orthopedic medical device testing services rank at the forefront of the industry with an incredibly broad scope of testing standards.
Orthopedic device testing is critical to ensure that medical devices perform their intended functions safely and satisfactorily. Working with an experienced company to complete medical device testing guarantees that you have all of the proper documentation in order when it comes time to submit your orthopedic device for review.
Orthopedic devices are subject to especially stringent testing protocols, and there are many different types of tests that might be appropriate depending upon the specific device and its function. Some of the most common types of orthopedic devices are implants, instruments, and materials, but even within those categories, there are different testing methodologies. For example, bone plates and reverse shoulders are both considered materials, but the former would only need to undergo simple testing for functions such as pullout and bending, whereas the latter would need to be tested for loosening and fatigue, among other things.
Similarly, hip and knee implants are common orthopedic devices that require extensive testing, and because each of these implants is intended to replace a large, multi-faceted joint, fatigue testing is a huge part of ensuring that these devices are safe and effective. Proper fatigue testing of different implant components shows the FDA precisely how much stress the implants can manage, which is an important detail for regulation.
Pull tests, strength tests, and fatigue tests are some of the most frequently-used orthopedical medical device testing methods, though they are obviously customized to the need of the particular device in question. With so many different types of orthopedic devices developed on a regular basis, it’s important that you work with a company that is equipped to customize testing solutions to your needs.
At Empirical Technologies, we’re Titanium subject matter experts with a long-established understanding of FDA requirements; our relationship with the agency allows us to stay on top of regulatory developments and provide you with all of the documentation you need to expedite the review process as much as possible.
Our 24-hour operations are facilitated by highly-qualified mechanical engineers, so we will work to execute your test plan as quickly and efficiently as possible. Capitalize on the years of expertise that Empirical Technologies uses in our testing processes; contact us for a quote today.