The Applied Technical Services Family of Companies (FoC) offers orthopedic device approval testing for the manufacturers of orthopedic devices. Manufacturers design orthopedic devices to prevent and treat musculoskeletal disorders, diseases, injuries, and conditions.
Technological advancement has led to improved medical outcomes for orthopedic medical device users worldwide and while medical device manufacturers deserve much of the credit for the increased quality of life for patients; third-party labs such as ATS help manufacturers develop products that are eligible for sale in national and international marketplaces and ensure that the products designs don’t pose any significant risks to end users.
What is Orthopedic Device Approval Testing?
Much like all medical devices, orthopedic devices must undergo evaluations and tests where professionals and agencies such as the FDA determine if a product is reasonably safe. These tests may range from biocompatibility tests that assess how the human body responds to the material to mechanical tests that determine the amount of stress and movement the product can withstand without failing.
The type of testing required varies with the type of product and the product’s safety risk classification. For example, a Class 1 medical device undergoes less strict testing parameters than a Class 3 device because the Class 3 device is high-risk and therefore essential to the health and life of the patient.
About Our Orthopedic Device Approval Testing
Our state-of-the-art medical device testing lab assists manufacturers in designing and testing their medical products to produce reliable and safe products that can succeed on the market. Our relationship with the FDA helps us stay to date with new regulations and regulations, ensuring that our clients’ products keep pace with the ever-evolving medical device market. Our medical device testing experts offer an extensive list of services that comply with standards issued by the FDA, ISO, and ASTM.
In addition to our orthopedic device testing services, we offer the following:
- Prosthetic testing services
- Medical device compliance testing
- Spinal implant testing
- Medical device regulatory consulting services
Contact Us
Please complete an online request form or call +1 (888) 287-5227 to learn more about our testing and consulting capabilities.
