The Applied Technical Services (ATS) Family of Companies offers our capabilities as a state-of-the-art material testing laboratory. This service is essential in the development process of up-and-coming medical device designs.
Material Testing
Material testing is a well-known discipline that can determine the properties of medical device components. Material testing can take an array of forms, validating and verifying the performance of components under testing. These methods produce qualitative and quantitative results to inform manufacturers about their materials’ capabilities.
Why Material Testing Laboratories Are Needed
Medical devices made using faulty or weak materials can seriously damage patients. Regulatory bodies minimize these risks by issuing standards for manufacturing companies to adhere to during testing. Material testing laboratories gather the data to inform manufacturers their product’s faults or weaknesses. Manufacturers can then make changes to the materials used, as well as the product’s overall construction.
When Risks Occur
If our technicians may discover risks in materials, they will provide manufacturers with test results so that clients may mitigate or eliminate them. Regulatory bodies, such as the Food and Drug Administration (FDA), will monitor the device materials throughout their market life to guarantee their quality and safety. They will also implement additional testing and control measures if any risks arise.
How Material Testing Laboratories Can Help
Manufacturers turn to material testing laboratories to assist them in gaining approval for their medical devices. Our Family of Companies offers a broad medical device material testing scope, allowing our labs to check for safety and functionality in materials and ultimately provide manufacturers with accurate results and reports.
Our Family of Companies
Our Family of Companies has achieved over 200 successful 510(k) submissions with the FDA. Our average review time is 131 days, 46 days faster than the industry average. The sector-specific expertise we offer helps manufacturers navigate the approval process that regulatory bodies enforce, and our customized approach allows them to achieve compliance quickly and efficiently. ATS offers:
- Over 20 years of experience
- Custom testing and protocols
- Comprehensive and proven solutions
- Additive component and manufactured testing
- Regulatory-ready test reports
- Our trusted reputation
- Experts in titanium subject matter
- An extension of your team, providing expert guidance and timely execution
Our Material Testing Laboratory
Our expert team of engineers conducts material testing in our 24-hour laboratory. We provide a complete material testing service package, offering manufacturers a wide range of testing solutions.
Common Tests We Perform
- Fatigue testing
- Shear testing
- Torsion testing
- Tensile testing
- Dedicated screw testing
- Instrument and life cycle testing
- Taber abrasion testing
- Wear and simulation testing
- Custom testing
- Non-standard testing
- Lot verification testing
Quality Assurance
The ATS Family of Companies holds an ISO/IEC 17025:2017 Test Laboratory Accreditation Certificate after passing rigorous auditing by the A2LA, qualifying us to perform tests and evaluations on medical devices compliant with ASTM/ISO standards and guidelines. By observing and utilizing GLP (good laboratory practices), our Family of Companies ensures the integrity of our results with lab monitoring, planning, recording, and reporting. We deliver accurate, traceable, and reproducible reports to manufacturers.
Contact Us
Contact the Family of Companies to learn more about our material testing laboratory today.
