Medical Device Testing with ATS
The Applied Technical Services (ATS) Family of Companies has provided mechanical testing capabilities for medical device clients. Our 24-hour operation and expert team of engineers makes us one of the leading support services in prototyping, testing, and consulting worldwide. Through various testing methods, our company helps medical device manufacturers ensure functionality, quality, and safety in their products.
Types of Medical Device Testing
Tensile testing: This method provides manufacturers with information about the tensile strength, yield strength, and ductility of the metallic material. Through testing, we can determine the force required to break a composite or stretch the specimen to that breaking point.
Shear testing: The medical device testing lab will move two forces in opposition to one another while pushing them in parallel directions. We then apply these forces to part of the assembly. This test determines shear strength, an important design characteristic on multiple types of fasteners.
Torsion testing: Technicians perform this type of medical testing by adding force to a fixed point. Manufacturers request it to help collect information such as torsional shear stress, shear modulus, and maximum torque, as well as to locate the material’s breaking angle.
Fatigue testing: A specialized form of mechanical testing that entails applying a cyclic load to a coupon or structure. This test can determine the sample’s fatigue life, identify critical locations, and show whether it may be susceptible to fatigue.
Wear and simulation testing: Wear testing evaluates a device’s performance in real-world conditions and determines whether it will perform its function properly. Also known as simulation testing, we use this medical device testing method to establish how much wear an implant can sustain in order to determine its usability under clinical conditions.
Instrument and life cycle testing: Instrument and life testing applies mechanical functions to a tested unit in a controlled environment over a specific duration of time. These units are observed for strengths, weaknesses, and failures over the testing period.
Lot verification testing: This testing confirms that each lot of products manufactured meet the minimum quality and safety criteria before release.
Non-standard testing: An umbrella term for many different types of testing ranging from novel materials to cutting-edge designs. Anything so new or unusual that it has no accepted testing standard falls into this category.
Axial compression testing: This is a medical device testing service where our technicians apply force to compress the specimen. Because it closely replicates the stresses that materials will encounter throughout their service lives, this method represents a significant portion of the fatigue and static testing we perform.
Driving torque: This test determines how much force a screw takes to drive into a known substrate. The Family of Companies has custom test beds to perform this specific type of testing. Customers can use the data gained from this testing to optimize designs and guarantee they are not overloading the bone.
Pull-out: Pull-out testing determines a screw’s resistance to being pulled out of its substrate. The medical testing labs often carry out this test after a driving torque test. Doing so helps customers better understand the level of hold their screw has inside a bone substrate.
Shear, fatigue, and lever: These tests assess how much force a screw can withstand when moving or levering due to a plate or rod. This testing determines how strong the fixation is without the substrate present.
Accreditation and Quality Standards
The ATS Family of Companies holds an ISO/IEC 17025:2017 accreditation (A2LA Cert No. 2142.01) for the highest number of medical device testing methods of any United States company. Our lab performs medical device testing and evaluations according to recognized ASTM and ISO standard specifications appropriate to our testing application. Both these qualification aspects set the Family of Companies apart from our competitors by reducing costs, establishing credibility, and improving efficiency.
The Family of Companies has medical device testing labs that equip manufacturers with the tools to get it right from the start. We get medical device manufacturers to market faster for less by helping them uphold their quality and safety standards.
