Mechanical Device Testing

WHAT SETs EMPIRICAL APART?
- Trusted Reputation
- Comprehensive & Proven Solutions
- Extension of your team, providing guidance & timely execution
- 25 + years of experience
- Unbiased 3rd Party Testing
- Industry Partnerships
- Regulatory-ready test reports
- Custom mechanical testing and protocols
- ISO/IEC 17025 Accredited Lab
- Cut through the Red Tape
- Speed to Market
WHAT IS MECHANICAL TESTING?

Mechanical device testing pushes individual components in products to their limits to determine if they need any modifications. At Empirical Technologies, we’ll test the tensile strength of components working together, the shear wear during movement, and the torsion of twisting components.

We push devices to see what happens under fatigue, determine the natural wear and simulation over time, and run constant tests on instruments and dedicated screws to discover their life cycles. We also test the axial compression of a device under repeated duress and consistently check to ensure your device meets all standards and regulations. With Empirical Technologies behind you, rest assured that your product will make it to market quickly and safely.
WHY IS MECHANICAL TESTING IMPORTANT
TYPES OF MECHANICAL TESTING SERVICES

Tensile Testing
Tensile testing applies force to separate the materials themselves and to determine if assembled parts can sustain pressure. This uncommon test often finds use when assembling cervical spine constructs.

Shear Testing
Shear testing determines the amount of forces materials sliding past each other can endure before failure occurs. Lumbar spine products often need this to simulate L4-S1 loading.

Torsion Testing
Tensile testing applies force to separate the materials themselves and to determine if assembled parts can sustain pressure. This uncommon test often finds use when assembling cervical spine constructs.

Fatigue Mechanical Testing Services
Fatigue testing looks at cyclic loading, the amount of loading cycles a device can handle before materials rupture or break. We commonly check the life cycle of medical devices to make sure they stay in service as long as possible.

Wear & Simulation Testing
Wear a.k.a. simulation testing evaluates the performance of devices in real world conditions. When developing all motion preserving joint constructions, testers push their limits to determine how well they perform and the wear they sustain with repeated use.

Instrument & Life Cycle
Empirical Technologies mechanical testing labs assist customers in improving the designs and functions of devices. We design custom tests that mimic clinical usage and operating room procedures to ensure they last as long as possible.

Lot Verification Testing
Lot Verification Testing confirms that products meet the standards and minimum criteria for release to pass FDA/501(k) Clearance, ASTM, and/or ISO regulations. These agencies require manufacturer verification so that practitioners purchase tools that will last and consistently achieve results.

Non-Standard Testing
Every year dozens of our customers push the envelope in medical technology. Empirical Technologies assists these clients by helping them understand regulation standards, developing unique tests, and tracking testing data to support submissions for cutting-edge devices.

Axial Compression
To mechanically test axial compression, we apply force to compress the equipment to see how a material’s fatigue resistance holds up under repeated use. This golden standard in medical device testing comprises most of the fatigue and static testing performed at Empirical Technologies.
DEDICATED SCREW TESTING
DRIVING TORQUE
PULL OUT
SHEAR, FATIGUE, AND LEVER
PROPERTIES THAT MECHANICAL TESTING EQUIPMENT MEASURES
Mechanical testing aims to exhaust all of the different stressors created during the regular use of medical devices. Empirical Technologies engineers test materials used in manufacturing depending on the device’s purpose.
Our team of experienced engineers can help you design custom tests and provide an exhaustive series of tests that look for different design flaws or shortcomings:
- How do materials hold up under physical pressure?
- What happens as surfaces come in contact repeatedly?
- How much twisting can malleable materials endure before failing?
- What is the typical wear and life cycle expected for components?
- How many times can components bending or stretching over time before losing their shape?
- Will metal sheets and coatings remain functional and not chip during regular use?
- Will your dedicated screws function when fasting a medical device to a substate like bone?
- Does everything adhere to the agency regulations?
WHEN SHOULD MECHANICAL TESTING BE DONE

In order for medical devices and products to be sold, mechanical testing needs to take place. After the initial design makes it to prototype, we want to see how it functions in its typical environment over time. Without the data gathered from pushing components to critical failure, regulatory agencies will not approve them.

Empirical Technologies wants to save you time and money. We work hard to stay up-to-date with changes and new requirements set in place by FDA/510(k) Clearance, ASTM, and ISO agencies while maintaining detailed reports for both the agencies and our clients. By remaining transparent and consistent with our data, we’ll get your approval ready 20-30% faster than industry standards for medical device testing.
WHY CHOOSE EMPIRICAL TECHNOLOGIES?
CUSTOM TESTING
OUR EXPERIENCE
Together, our company shares over 75 years of medical service, regulatory approvals, and testing experience. We lead the way in evaluating devices and help our customers get regulatory approval in whatever jurisdiction they operate. With thousands of projects and preformed testing services requiring simple 510ks to PMA/IDEs, we integrate our mechanical testing team into yours. By combining our strengths, we can seamlessly transfer information between your team and ours. We’ll monitor and update progress regularly to you so that your internal team remains informed. Make Empirical a part of your team to combine our success with yours!
We utilize our expertise in mechanical testing to lower your costs and time to market by designing test plans that meet your team’s goals. We help our customers get their products to market 20-30% faster than industry standards in jurisdictions all over the world. Put Empirical Technologies mechanical testing services and regulatory expertise to work to find the best path forward while saving your team time and money.