Empirical Quality

Quality Makes the Difference When Seeking Regulatory Approval

Empirical test frame

The Empirical family of companies is committed to providing the highest quality medical device testing services for our customers, including accurate 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 are delivered at a competitive price.

At present, 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 achieving numerous industry-recognized ISO/IEC 17025:2005 accreditations, our staff employs an ISO-recognized Quality Assurance System (QAS) and upholds an organization-wide dedication to confidentiality. Empirical employees must undergo training in both the QAS and confidential document handling. As a matter of course, all Empirical customer relationships are deemed confidential.

Empirical’s devotion to quality medical device testing provides you with 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 it firsthand.

ISO/IEC 17025:2005 Accreditation

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

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, Empirical assures integrity in lab planning, monitoring, recording and reporting.