In a recent industry letter, the FDA’s Center for Devices and Radiological Health urged medical device firms to use discernment when selecting third-party labs for performance testing. The letter described an uptick in premarket submissions with unreliable and fraudulent test data from third-party labs, particularly overseas providers. Unqualified third-party labs may provide firms with performance test results that include duplicate, inaccurate, or fabricated data.
Why ATS Is the Right Choice as Your Third-Party Testing Lab
The FDA recommends that firms verify their third-party lab of choice is qualified first to test a product and second to accurately collect and analyze data. ATS’s qualifications speak for themselves. Our proven competence in medical device testing and successful quality audits have earned our organization ISO/IEC 17025:2017 accreditation from the A2LA.
Quick FDA 501(k) approval relies on a submission demonstrating substantial equivalence to an approved device. If they cannot verify the test data illustrating a device’s performance and safety, the FDA cannot authorize it for legal distribution. As a result, this industry letter also recommended that firms review third-party test data for inaccuracies and falsehoods that will cause the FDA to reject their submission.
ATS Testing Labs
ATS is more than qualified to fulfill our clients’ medical device testing needs. Our labs maintain ISO/IEC 17025:2017 accreditation through the A2LA with scopes covering mechanical, chemical, electrical, and nondestructive testing procedures, as well as calibrations. We employ teams of experts with decades of experience testing medical devices and equipment. We can assess how design materials and structures hold up to the everyday forces, temperatures, and motions required for human use.
We deliver thorough analysis and detailed reporting so clients can clearly understand their device’s capabilities and limits. Additionally, we are an internationally recognized firm with an ISO 9001:2015 Quality Management System and several ISO 17025 accreditations that align with Good Laboratory Practices (GLPs) for nonclinical studies.
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ATS delivers trustworthy results, thorough analysis, and a reduced wait time. Call +1 (888) 287-5227 to schedule medical device testing today.
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