Static, dynamic and wear testing for your regulatory submission
At Accutek, we understand that bringing innovative medical device technology to the marketplace is a high‐risk venture. That is why we strive to provide our clients with absolute testing certainty by providing accurate and reliable results in a timely fashion.
Accutek Testing Laboratory is an ISO 17025 (A2LA) Accredited Laboratory. Accutek routinely performs static and fatigue testing, wear testing, and failure analysis on medical devices and orthopedic implants to ASTM and ISO standards, as well as many other regulatory body specifications.
Our engineering professionals are experienced in every stage of testing for medical device design and development - from test protocol development to prototype/feasibility trials to testing for 510(k) and other regulatory submittals to failure analysis and material validation/identification.
Extensive Medical Device and Implant Testing experience:
- Spinal Assemblies and VBR’s
- Bone Screws, Rods and Plates
- Shoulders and Ankles
- Small Bone
- Device Instruments
Accutek boasts over 65 axial fatigue frames and more than 10 torsional fatigue frames - we have the capacity to meet all your testing needs. Our attention to detail and dedication to quality throughout your project produces quantifiable results in a timely manner. We work hard to understand your needs before embarking on a test.
Accutek has worked with small start-up companies to large, “blue chip” medical device manufacturers. We approach each project with a high level of attention to the objectives of testing, to ensure we provide only the necessary testing.
We also recognize that test methods in ASTM, ISO and other regulatory specifications may not always be suitable for your device, or that there may not be existing test standards for your innovative device. Our test engineers will work with you to develop a customized and cost-effective medical device testing plan and, if necessary, customize test equipment to the exact testing needs of your organization.