Empirical Technologies Corporation
Empirical Technologies is a leading provider of mechanical testing, regulatory consulting, and certification services for medical devices and other industries. With over 20 years of experience, they specialize in testing standards such as ASTM, ISO, and FDA compliance, helping clients bring their products to market faster and more reliably. They serve a wide range of industries including medical, aerospace, and industrial sectors, and are committed to quality, integrity, and partnership in delivering comprehensive testing solutions.
Industries
Nr. of Employees
small (1-50)
Empirical Technologies Corporation
4628 Northpark Drive, Colorado Springs, CO 80918
Services
Comprehensive mechanical testing package including static, dynamic, fatigue, tensile, shear, torsion, wear and axial compression tests with regulatory‑ready reporting.
High‑ and low‑cycle fatigue testing, axial and torsional fatigue, fastener fatigue, rotating beam and life‑cycle curve generation up to multi‑million cycles.
Material and component testing to measure modulus, yield, ultimate tensile strength, ductility, flexural modulus and related properties using calibrated universal testing machines.
Regulatory strategy and submission support including 510(k) preparation, De Novo pathway assistance, gap analysis, and submission document assembly.
EU MDR transition planning, gap analyses, quality system changes, technical file and design dossier support, and mock audit assistance.
Delivery of testing under an ISO/IEC 17025:2017 accredited framework with documented quality systems and GLP‑aligned practices for nonclinical studies.
Comprehensive mechanical testing package including static, dynamic, fatigue, tensile, shear, torsion, wear and axial compression tests with regulatory‑ready reporting.
High‑ and low‑cycle fatigue testing, axial and torsional fatigue, fastener fatigue, rotating beam and life‑cycle curve generation up to multi‑million cycles.
Material and component testing to measure modulus, yield, ultimate tensile strength, ductility, flexural modulus and related properties using calibrated universal testing machines.
Regulatory strategy and submission support including 510(k) preparation, De Novo pathway assistance, gap analysis, and submission document assembly.
EU MDR transition planning, gap analyses, quality system changes, technical file and design dossier support, and mock audit assistance.
Delivery of testing under an ISO/IEC 17025:2017 accredited framework with documented quality systems and GLP‑aligned practices for nonclinical studies.
Expertise Areas
- Mechanical testing for medical devices
- Orthopedic and spinal implant testing
- Fatigue and durability testing
- Implant and prosthesis structural testing
Key Technologies
- Universal testing machines (electromechanical and hydraulic)
- Fatigue testing rigs (rotating beam, axial, torsion)
- Wear simulators and physiological environment chambers (heated saline)
- Torsion and torque‑angle measurement systems
News & Updates
Nathan Wright from Empirical Technologies will moderate an expert panel at the Orthopedic Design and Technology Forum 2024, discussing additive manufacturing in the medical industry.
The FDA recommends verifying the qualification of third-party labs for performance testing. Empirical Technologies is accredited and qualified to perform reliable testing.
Empirical tested and supported the FDA clearance of Curiteva’s lumbar cage using ASTM F2077 standards, achieving rapid clearance in 58 days.
An overview of the history and development of prosthetic limbs from ancient times to modern innovations, highlighting key advancements and future directions.
Nathan Wright from Empirical Technologies will moderate an expert panel at the Orthopedic Design and Technology Forum 2024, discussing additive manufacturing in the medical industry.
The FDA recommends verifying the qualification of third-party labs for performance testing. Empirical Technologies is accredited and qualified to perform reliable testing.
Empirical tested and supported the FDA clearance of Curiteva’s lumbar cage using ASTM F2077 standards, achieving rapid clearance in 58 days.
An overview of the history and development of prosthetic limbs from ancient times to modern innovations, highlighting key advancements and future directions.