Mechanical Device Testing

Mechanical testing determines qualities of existing devices and pushes the materials used to craft components to their limits. Empirical Technologies offers a complete mechanical testing service package that provides unsurpassed technical reports to both you and regulation agencies.
Request an Estimate
Our knowledgeable team will also assist clients attempting to push new standards, and ensure their device meets all the regulations needed to release products to market. With our proven track record of getting clients products to market 20-30% faster than industry standards, let Empirical Technologies mechanical consulting teams and labs take the stress and fatigue out of testing needed to comply with FDA/501(k) Clearance, ASTM, and ISO regulations.

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

Without testing the mechanical components in devices repeatedly over an extended period of time, a product may look ready and suddenly start malfunctioning. If this happens during patient visits, either the practitioner or their clients could be injured. Empirical Technologies mechanical device laboratories exhaust medical devices to account for every different scenario practitioners will find in their everyday practice. We make products safe.

TYPES OF MECHANICAL TESTING SERVICES

Empirical Technologies mechanical testing services push medical devices and individual parts to their breaking points to determine if the materials used will endure regular use. Depending on the purpose of the device, we offer tests that match the motions they use in clinical and everyday settings. Check out our comprehensive list of tests to learn more about how we’ll help your design make it to market:

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

Dedicated screws hold medical devices in place after surgeries and during product use. By testing how the screws hold up under regular and intense use, patients and doctors alike can trust that most medical implants and devices will work for years to come. Take a look at some of our common tests to learn more about how we push dedicated screws to their limits:

DRIVING TORQUE

The force taken to drive a screw into a known substrate varies. Depending on the size of the medical device and the bone/ product to which it’s fastened, engineers create custom beds to perform testing. They optimize the design so that the screws don’t overwhelm the substrate.

PULL OUT

Pull out refers to the resistance of a screw being pulled (or sometimes levered) out of its substrate. When done at the end of a driving torque test, this helps mechanical customer testing companies and customers understand how much hold the screw has in the substrate.

SHEAR, FATIGUE, AND LEVER

To determine how much force a screw can take as the plate or rod attached to it moves, Empirical Technologies tests the shear, fatigue, and lever functions of dedicated screws. Engineers often remove the substrate from the equation to understand how strong the fixation remains independently.

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?

Empirical Technologies extensive expertise allows us to design tests that meet any customer needs. We partner with clients to help them navigate regulatory requirements and understand testing purposes. Whether customers create novel material or a cutting-edge implant design, our experience from testing hundreds of projects from inception to realization focuses on keeping the goal of approval and the reality of costs front and center. If current regulations lack a standard for a project, our professional team will competently craft a protocol to test your device. We keep up to date with standards and understand what regulatory agencies look for when approving medical equipment so that you can get your device cleared as quickly as possible.

CUSTOM TESTING

As a mechanical testing company, Empirical Technologies endeavors to help customers meet safety and efficacy goals. Our expertise outside of mechanical testing services focuses on maintaining regulatory, manufacturing, and industry expertise to help customers actualize their goals despite a changing regulatory environment. At Empirical, we sit down with our customers to review every project and meet the unique challenges their devices bring to us. From these talks, we’ll develop custom tests to push device mechanisms to critical failure in order to approve or improve designs to pass regulations.

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.

FAQ

Anyone seeking to pass regulations and standards needs to get their device tested. Once you’ve got a working prototype, let us put it to the test to help you determine what changes or modifications will keep it running effectively and efficiently for as long as possible.
Practitioners using medical devices and the recipients that receive implants and treatments should be able to trust the technology developed for them. The three big regulatory agencies we work with include The U.S. Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and the American Society for Testing and Materials (ASTM).
As our team tests your devices, we send regular updates to your team and regulatory agencies. We want our process to be transparent to all parties involved in case anyone wants more information.