QUALITY STANDARDS

Empirical Quality

Quality Makes the Difference When Seeking Regulatory Approval

Empirical holds the widest scope of test standards under ISO/IEC 17025 : 2005 currently available in the United States. We are committed to providing an exceptional level of customer service, partnership, execution, and reporting for our clients across the globe.

ISO/IEC 17025:2005 Accreditation
AS9100D Certification
ISO 9001:2015 Certification

The 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 scope of test standards under ISO 17025 accreditation 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 17025:2005 accreditation, 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. We invite you to schedule a tour of our facility to see our operations firsthand.

ISO/IEC 17025:2005 Accredited

The QMS for medical device testing is based upon the requirements set forth by the most current version of ISO/IEC 17025 : 2005.

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 17025:2005 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 17025:2005-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 multidiscipline 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 is AS9100D Certified to provide mechanical testing for Aerospace & Defense

As part of extended services into Aerospace & Defense testing, we are proud to have obtained AS9100D(2016) based on ISO 9001:2015 certification.

Empirical provides Mechanical Testing, Research and Development, Engineering Services, Machining Capabilities, and Strategic Consulting to a global market place. As a Small and Woman owned business, we are dedicated to inclusion and diversity and providing our clients with highest quality services delivered on-time, every time.

Empirical can design and manufacture custom test blocks and fixtures in our onsite machine shop to streamline your testing project timeline.

Empirical experts leverage decades of experience to produce exceptional quality of complex components, implants and instruments. We provide turn-key solutions using the latest in machining technology that include 3, 4, and 5-axis mills.

As the holder of Orion’s ISO 9001:2015, we can provide quality machining services to support your test project. Having an in-house machine shop allows for a more streamlined and cohesive project timeline. 

EMPIRICAL’S CURRENT SCOPE OF ACCREDITATION FOR MEDICAL DEVICE TESTING INCLUDES:

  • Dental
  • Extremities
  • Joint Replacement Implants
  • Spine