Medical Device Mechanical Testing Regulations

Prostheses and implants can do great harm if deficient, so the FDA sets stringent mechanical testing requirements for medical device manufacturers and distributors. Devices intended for bodily implantation must prove they can withstand the loads and conditions within and without a human body. As such, manufacturers and distributors may request mechanical testing from qualified third-party labs before submitting a device for 510(k) clearance or Premarket Approval (PMA).
Medical Device Testing with ATS FoC
The ATS FoC offers a variety of medical device tests and services for product verification and validation. We work with devices and assemblies classified as moderate to high-risk (FDA Classes II and III) to ensure quality and safety. Clients may contact us throughout the design and development of an implant or component for regular testing.

Implants and Prostheses:

Systems and Devices:

Standards-Based Testing

After development, we can test function, quality, and safety according to industry standards from ASTM, ISO, and other relevant organizations. Our technicians can also determine a device’s mechanical and material properties.

Some of our most popular mechanical tests and standards include:

Meet the ATS FoC
We are a network of consulting engineering, calibration, testing, and inspection firms known collectively as the ATS Family of Companies (FoC). Founded in Atlanta in 1967, ATS has built a reputation for responsiveness and dependability. Today, we operate ISO/IEC 17025-accredited labs in strategic locations nationwide. ATS also meets ISO 9001:2015 requirements for a Quality Management System.
With over 20 years of experience in medical device testing, the ATS FoC is qualified for third-party testing and verification. Our employees have undergone extensive training in confidentiality, testing, and reporting. Additionally, we can tailor ASME, ISO, and other relevant standards-based testing to suit our clients’ needs or create non-standard tests custom to client specifications.
Contact Us
Please call +1 (888) 287-5227 to learn more about how the ATS FoC can support your medical device’s compliance with mechanical testing regulations.

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Medical Device Testing