The Applied Technical Services (ATS) Family of Companies takes pride in our extensive and efficient medical device product testing capabilities. We are committed to providing high-quality testing services to our clients.
Why Medical Device Product Testing Is Necessary
Medical device testing is necessary for any product development cycle requiring regulatory marketing approval. It consists of a series of specific tests verifying that the product’s intended service conditions will not impede its performance or reliability, thus preventing potential patient risks.
What We Offer
Our company has a broad scope of medical device product testing, including dental implant testing, extremity implant testing, joint implant testing, and spinal implant testing. Each product we work with needs a specific type of testing. For example, dental implants require fatigue testing to ensure the implant’s integrity by simulating a worst-case scenario after exposing them to cycles of forces until they fail.
Common Mechanical Testing We Perform
Tensile Testing: A mechanical test that applies force to separate material or assembly from each other.
Shear Testing: Test that applies two opposite forces to a part of the assembly along a parallel axis.
Torsion testing: Technicians perform this type of medical testing by adding force to a fixed point. Manufacturers request it to help collect information such as torsional shear stress, shear modulus, and maximum torque, as well as to locate the material’s breaking angle.
Fatigue Testing: The cyclic loading of a specimen that uses material fatigue as an estimate for the specimen’s lifespan to verify whether it meets design criteria.
Wear & Simulation Testing: A test that evaluates the performance of a device when put under real-world conditions.
Instrument & Life Cycle Testing: This test helps customers improve their designs to get better performance and longer service lives out of their products.
Lot Verification Testing: We confirm that each lot of product meets the minimum requirements for market release.
Non-Standard Testing: A broad range of testing methods with no accepted standard.
Axial Compression Testing: A mechanical testing service in which we apply compressive forces to a specimen.
Dedicated Screw Testing: This includes driving torque, pull-out, shear, fatigue, and lever testing. Driving torque and pull-out testing go hand in hand; Driving torque measures the force it takes to push a screw into a known substrate, while pull-out measures the resistance a screw displays against being pulled out. Shear, fatigue, and lever showcase how much force a screw endures when the plate or rod keeping it in place is moving.
Quality Assurance
The ATS Family of Companies possesses the widest range of accredited mechanical testing standards for medical devices in the United States. We are dedicated to continually bettering our standards at every available opportunity. Furthermore, we have ISO/IEC 17025:2017 accreditations and a staff that adheres to an ISO-recognized Quality Management System (QMS).
Our organization possesses a team of highly trained and experienced mechanical technicians ready to help your company execute its medical device product testing plans. We assist clients in obtaining reliable test reports that will help them meet global regulatory requirements, such as FDA and CE marketing approval. We invite you to request a quote on your next medical device product test with us today.
