For Our ASTM & ISO Medical Device Testing
EMPIRICAL QUALITY STANDARDS
- ISO 14801: Dentistry – Implants – Dynamic Fatigue Test for Endosseous Dental Implants
SCOPE FOR OUR ASTM & ISO TESTING SERVICES
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.