For Our ASTM & ISO Medical Device Testing

EMPIRICAL QUALITY STANDARDS​

Quality makes the difference when seeking regulatory approval!

Empirical holds the widest scope of test standards under ISO/IEC 17025 : 2017 currently available in the United States and Europe. We are committed to providing an exceptional level of customer service, partnership, execution, and reporting for our clients across the globe.

Scope of Accreditation

SCOPE FOR OUR ASTM & ISO TESTING SERVICES

Empirical is committed to providing the highest quality mechanical testing services for our customers, including accurate, reproducible and reliable testing results, professional technical reporting and a rapid response to any issue. Above all, our services are designed to be sensitive to a fast-paced product development environment and delivered at a competitive price.

Empirical holds the widest range of accredited test standards for medical devices currently available in the United States and is dedicated to continually pursuing standards as they become available.

In addition to ISO/IEC 17025:2017 accreditations, our staff employs an ISO-recognized Quality Management System (QMS) and upholds an organization-wide dedication to confidentiality. Empirical employees must undergo training in both the QMS and confidential document handling.

As a matter of course, all Empirical client relationships are strictly confidential. Empirical’s devotion to quality services gives you a competitive advantage by reducing costs, establishing credibility, improving efficiency and enhancing profitability.

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  • ISO/IEC 17025:2017 ACCREDITED

    The QMS for medical device testing is based upon the requirements set forth by the most current version of ISO/IEC 17025:2017.

  • WHY PERFORM MECHANICAL TESTING?

    Mechanical testing is a necessary step of any product development cycle for a medical device requiring regulatory marketing approval.

  • WHY USE AN ACCREDITED LAB?

    By observing and utilizing good laboratory practices (GLP), Empirical assures integrity in lab planning, monitoring, recording and reporting. We deliver reproducibility, traceability and accuracy in all that we do for you.

EMPIRICAL IS DEDICATED TO ACHIEVING INDUSTRY-RECOGNIZED CERTIFICATION

Empirical is the global leader in medical device testing and holds A2LA accreditation for the largest number of medical device testing methods in the United States. As the holder of the A2LA’s ISO/IEC 17025:2017 Test Laboratory Accreditation Certificate #2142-01-A2LA, Empirical is recognized as capable and qualified to perform testing and evaluation of medical devices in compliance with ASTM/ISO guidelines in the area of finished medical devices.

Empirical achieved this accreditation Dec. 2, 2003. More international regulatory agencies require testing to be performed by an ISO 17025:2017 accredited lab to meet their standards for clearance/approval. This accreditation has provided Empirical with a competitive advantage by reducing costs, establishing credibility and improving efficiency for our clients.

While some lab accreditations involve only minimal review of a laboratory’s qualifications, an A2LA accredited lab must meet rigorous internationally recognized standards. The A2LA annually audits and inspects Empirical, ensuring our lab meets testing, calibration and quality standards set by the organization, which is recognized by more than 30 federal, state and local government associations.

Established in 1978, A2LA is the largest multi-discipline accreditation organization in the United States. Empirical will pursue any additional accreditation classifications that become available. Please contact us to discuss the custom services we provide where accreditation has yet to become available.

EMPIRICAL SUPPLIER QUALITY MANUALS

Empirical is the global leader in medical device testing and holds A2LA accreditation for the largest number of medical device testing methods in the United States.
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