Medical Device Testing Services offers customized mechanical tests for virtually any medical device. While FDA, ASTM, CE, and ISO standards are sometimes available, test protocols to meet these standards may need to be modified for unique designs. In these cases, or when no established protocols are available, MDT works closely with the customer in an iterative process to ensure tests meet the intent of the various agency guidelines.
Examples of custom tests performed by MDT include:
Tests are conducted in accordance with ANSI/ISO/IEC 17025-2005 and our internal Quality Policy. MDT Services prepares a test plan for each design. The test plan components are reviewed and validated throughout the process at stages defined in the test plan. The final test process and/or fixtures are validated to ensure that design and development outputs meet the customer's input requirements and specifications. Validation reports include a description of the suitability of materials, the performance data, and reliability data of the customized equipment and test protocols.
MDT uses the ElectroForce® 3000 Series test instruments, which operate using a linear motor as well as SmartTest Servopneumatic and MTS Servohydraulic test instruments rated at higher loads. These instruments perform a variety of materials tests including tension/compression, axial-torsion, multi-axis loading, fatigue and dynamic materials characterization. For vascular devices, MDT uses ElectroForce 9100 Series stent testers, which operate on the principle of fluid displacement. Linear motors on each end of the tester apply a sinusoidal pumping action which forces fluid into and out of mock arteries causing them to expand and contract. A laser micrometer measures the radial strain by measuring the outside diameter of the arteries at 1200 scans per second. The laser heads are mounted on a micrometer to accommodate measurements along the length of the stent.
Tests are conducted in accordance with ANSI/ISO/IEC 17025-2005. Testing schedules and resource needs are determined during project kickoff meetings with MDT engineers and the customer. Services are performed in accordance with standard operating procedures and test protocols specific to the service. Standard tests do not begin without a protocol signed by both the customer and an MDT representative. For feasibility or non-standard tests, MDT will develop a method and protocol with customer input and will review the final process with the customer prior to initiation of the test.
The test equipment software monitors the cycle count, displacement, and load throughout the duration of the test. MDT engineers monitor the test daily and record the temperature and other parameters for the system. MDT sends weekly updates to ensure customers are apprised of the status of their test. Updates include raw data collected throughout the week for the customer’s analysis.
MDT offers several inspection methods including:
Tests are conducted in accordance with ANSI/ISO/IEC 17025-2005. In compliance with this standard, MDT test reports include comprehensive documentation and summary of the test protocol and results. All reports are GLP compliant and can be submitted directly to regulatory agencies. Any test method deviations, additions, or exclusions are documented and reviewed with the customer prior to beginning the test. Information within the report includes the specific test conditions, statements of compliance with test protocol, and the estimated measurement uncertainty. The reported results only relate to the items tested. Any opinions and interpretations provided by MDT are clearly marked as such. Any additional information required by customer-specific methods will also be noted. At the conclusion of the test, MDT provides the customer with a Microsoft Windows formatted CD containing copies of all raw data, inspection results, and other information collected during the test (see example test reports).
Please take a few moments to tell us more about your device and test requirements in our short questionnaire, and we will be happy to provide you with a quote.