The Applied Technical Services Family of Companies (ATS FoC) conducts comprehensive medical device wear testing to help our clients understand how their device will perform in real-world conditions. Our wear testing supports safer products, stronger regulatory submissions, and more predictable development cycles.
ATS provides wear testing that is precise, efficient, and aligned with industry expectations and regulatory standards. Our team prioritizes clear communication, dependable results, and a partnership‑driven approach that supports each client’s technical and compliance needs.
Wear Testing Medical Devices
Wear testing evaluates how friction, motion, and environmental conditions affect a test subject over time. These insights help teams confirm design choices, validate materials, and reduce the chance of unexpected failures. The process also supports documentation for regulatory bodies that require evidence of durability and long‑term performance.
What Types of Medical Devices Require Wear Testing?
Many devices benefit from structured wear testing. The need depends on how the device moves, interacts with tissue, or experiences repeated cycles. Manufacturers, product developers, and research teams rely on wear testing to confirm that a device performs as intended throughout its expected life cycle. Some of the medical device types that require wear testing include:
- Implantable devices, such as joint replacements and spinal components
- Surgical instruments that undergo repeated cleaning and use
- Drug‑delivery systems with moving parts or seals
- Diagnostic equipment with mechanical interfaces
- Wearable devices exposed to daily environmental stress
What Standards and Regulations Apply to Medical Device Wear Testing?
ATS offers medical device wear testing to a wide range of recognized standards, in addition to custom-tailored testing to client parameters. These standards help ensure consistency, repeatability, and regulatory acceptance:
- ISO: implants, materials, and mechanical durability
- ASTM: friction, abrasion, and fatigue
- FDA: guidance related to device performance and long‑term reliability
Compliance with these standards supports stronger submissions and clearer documentation, helping teams demonstrate that testing followed accepted industry practices.
How Can Wear Testing Reduce Risk During Product Development?
Wear testing provides early insight into how a device responds to real‑world conditions. By addressing issues early, manufacturers can streamline development and improve confidence in final product performance. This information helps our clients:
- Identify potential failure modes
- Improve material selection
- Support design refinements
- Reduce costly late‑stage changes
- Strengthen risk‑management documentation
ATS: Our Process Is Rooted in Partnership
ATS delivers wear testing with a focus on accuracy, clarity, and collaboration. Our dedicated medical device testing experts work closely with each client to understand device function, testing goals, and regulatory expectations. We tailor each test plan to the device’s unique characteristics and provide clear, actionable reporting. With industry-leading technicians and engineers, ISO 9001:2015-registered and ISO/IEC 17025:2017-accredited testing laboratories, cutting-edge technologies, and an unwavering commitment to customer satisfaction, ATS is proud to be the preferred medical device testing provider for some of the world’s most prestigious manufacturers and organizations. In addition to wear testing, some of our most commonly requested medical device testing services include orthopedic implant testing, lumbar spine implant testing, cervical spine implant testing, fatigue testing, and substantial equivalence analysis. For clients seeking regulatory compliance strategy development, ATS also offers hands-on consulting services.
Contact Us
For medical device wear testing from the proven experts at ATS, submit a web request form or call +1 (888) 287-5227 today.
