Scope:
Medical Device Testing Services offers standardized and custom uni-axial mechanical tests for orthopedic devices. While FDA, ASTM, CE, and ISO standards are 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 interative process to ensure tests meet the intent of the various agency guidelines.
Examples of Standardized Orthopedic Tests:
Examples of Customized Orthopedic Tests:
Design & Validation:
MDT 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 interface between the participating groups are managed to ensure effective communication and assignment of responsibility. 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 customers 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.
Equipment:
MDT uses 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.
Test Protocol & Set Up:
MDT tests are conducted in accordance with ANSI/ISO/IEC 17025-2005. Testing schedules and resource needs are determined during project kick off meetings with MDT engineers and the customer. The 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. Click here to view a sample Test Protocol.
Test Monitoring & Weekly Updates:
The test equipment software monitors the cycle count, load and displacement throughout the duration of the test. 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.
Inspections & Service Offered:
MDT offers several inspection and monitoring methods including:
Test Reports:
Tests are conducted in accordance with ANSI/ISO/IEC 17025-2005. In compliance with this standard, MDT test reports include comprehensive documentation of the test protocol and results. 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, or other information collected during the test. Click here to view a sample Test Report.
Please take a few moments to tell us more about your specimen and test requirements in our short questionnaire, and we will be happy to provide you with a quote.
