Quality Makes the Difference When Seeking Regulatory Approval
Empirical holds the widest range of and highest quality level of accredited test standards or certificates for medical devices currently available in the United States. We are committed to providing the highest standards in service and accreditations for our customers.
The Empirical family of companies 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 17025:2005 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 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 Accreditation
The QAS for medical device testing is based upon the requirements set forth by the most current version of ISO/IEC 17025.
Mechanical testing is a necessary step of any product development cycle for a medical device requiring regulatory marketing approval.
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.
ISO/IEC 17025:2005 Accreditation
Empirical Testing Corp. is Dedicated to Achieving Industry-Recognized Certification
Empirical Testing Corp. 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’s current scope of accreditation for testing includes:
- ISO 14801: Dentistry – Implants – Dynamic Fatigue Test for Endosseous Dental Implants
- ASTM F382: Standard Specification and Test Method for Metallic Bone Plates
- ASTM F384: Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
- ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws
- ASTM F564: Standard Specification and Test Methods for Metallic Bone Staples
- ASTM F1264: Standard Specification and Test Methods for Intramedullary Fixation Devices
- ASTM F1541: Standard Specification and Test Methods for External Skeletal Fixation Devices
- ASTM F2183: Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants
- ASTM F2502: Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants
Joint Replacement Implants
- ASTM F1223: Standard Test Method for Determination of Total Knee Replacement Constraint
- ASTM F1357: Standard Specification for Articulating Total Wrist Implants
- Section 6.3: Range of Motion of the Device Before Implantation
- ASTM F1378: Standard Specification for Shoulder Prostheses
- ASTM F1714: Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip-Designs in Simulator Devices
- Annex 4: Method for Cleaning and Weighing of Specimens Only
- ASTM F1781: Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
- Section 6.2: Range of Motion of the Device Before Implantation
- ASTM F1800: Standard Test Method for Cyclic Fatigue Testing of Tibial Tray Components of Total Knee Joint Replacements
- ASTM F1820:Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device
- ASTM F2009: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
- ASTM F2025: Standard Practice for Gravimetric Measurements of Polymeric Components for Wear Assessment
- Annex 1: Method for Cleaning and Weighing of Specimens Only
- ASTM F2028: Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
- ASTM F2118: Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
- ISO 7206-4: Implants for Surgery – Partial and Total Hip Joint Prostheses – Determination of Endurance Properties and Performance of Stemmed Femoral Components
- ISO 7206-6: Implants for Surgery – Partial and Total Hip Joint Prostheses – Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components
- ISO 7206-8: Implants for Surgery – Partial and Total Hip Joint Prostheses – Endurance Performance of Stemmed Femoral Components with Application of Torsion
- ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- ASTM F1798: Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- ASTM F2077: Test Methods for Intervertebral Body Fusion Devices
- ASTM F2193: Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device under Static Axial Compression
- ASTM F2346: Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
- ASTM F2423: Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
- ASTM F2624: Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants
- ASTM F2694: Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
- ASTM F2706:Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
- ASTM F2789: Standard Guide for Mechanical and Functional Characterization of Nucleus Devices (Except Viscoelastic Testing)
- ASTM F2790: Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses
- ISO 12189: Implants for Surgery – Mechanical Testing of Implantable Spinal Devices – Fatigue Test Method for Spinal Implant Assemblies Using an Anterior Support
- ISO 18192-1: Implants for Surgery – Wear of Total Intervertebral Spinal Disc Prostheses – Loading and Displacement Parameters for Wear Testing and Corresponding Environmental Conditions for Test
ISO 9001:2015 & ISO 13485:2016 Certifications
Empirical Machine is a Globally Recognized, Full-Service Precision Manufacturer
Empirical Machine 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 and Swiss-type and conventional turning.
As the holder of Orion's ISO 9001:2015 and ISO 13485:2016 Certifications, Empirical Machine is recognized as a certified facility in the area of finished medical devices. This certification provides Empirical Machine clients with a competitive advantage by partnering with a quality focused organization that delivers in timely manner which translates to a quicker time to market.