The Applied Technical Services (ATS) Family of Companies is an accredited mechanical testing provider offering comprehensive orthopedic device testing. Our wide variety of testing standards places us at the forefront of the orthopedic device testing industry.
What Orthopedic Device Testing Is
Orthopedic device testing determines the stability of a medical implant and its impact on surrounding bone. This type of testing must replicate how an orthopedic implant will mechanically load within the host’s musculoskeletal system.
These devices must be subject to stringent testing protocols. The type of testing they will undergo depends upon the specific device and how it functions.
Why Orthopedic Device Testing Is Vital
Orthopedic device testing is vital in ensuring that devices function safely and satisfactorily. Working with an experienced testing company gives clients the confidence that they have the proper documentation before submitting their orthopedic device for review.
Common Orthopedic Devices Include:
- Implants
- Dental
- Spinal
- Joint
- Extremities
- Instruments
- Surgical screws
- Surgical staples
- Circular saws
- Scalpels
- Materials
- Metals
- Alloys
- Acrylic bone cement
- Polyethylene
- Calcium phosphate coatings
- Metallic thermal spray coatings
Types of Testing
Testing providers offer different types of mechanical testing methodologies for use with orthopedic devices. For example, reverse shoulder must undergo thorough loosening and fatigue testing, while the bone plates only need simple bending and pullout testing.
Another example is hip and knee implants. These devices require extensive testing since they replace larger, multifaceted joints. Different implants and components must undergo fatigue testing to verify that they can manage to ensure proper safety and efficiency.
Custom Testing
Testing companies can specify customized testing methods for the device under test. Since there are always an array of orthopedic devices in their developmental stages, it is critical that clients work with a fully equipped company ready to customize any test to find the correct solutions. We provide sample machining and fixture fabrication services in-house to support our clients’ custom testing needs.
Our Family of Companies
With more than 20 years of medical device testing experience, our Family of Companies is an innovator in the industry—especially when it comes to orthopedic devices. We provide full evaluations of orthopedic devices to ensure that surgical implants display the appropriate mechanical properties eventual clinical usage will require. Furthermore, we utilize our evaluations to produce rigorous reports ready for regulatory body submission.
Quality Assurance and Standards
The ATS Family of Companies has a deep understanding of the FDA requirements. Our relationship with the organization keeps us up to date with regulatory developments to provide clients with ample amounts of documentation to expedite review processes as often as they deem necessary.
Our 24-hour operation employs highly skilled mechanical engineers. We are an A2LA ISO/IEC 17025:2017 accredited mechanical testing lab specializing in various medical device testing methods. Contact us for a quote on your orthopedic device testing today.
