Accurate measurement is the bedrock of any medical device manufacturing process. As a means of ensuring consistency and accuracy, we adhere to strict metrology services and traceability capable of dimensional and performance assessments.
Why is metrology important?
Metrology is the science of not just measurement but its application. Designed with the patient in mind, our infrastructure ensures that all our products are created and tested using universally accepted SI units and tracked to show complete transparency and control from planning and prototyping to the final rollout.
Europlaz and NIST – Metrology for Medical Devices
A key component of our medical product prototyping is ensuring measurements are accurate and consistent. To meet clients’ demands, we offer a full metrology service capable of dimensional and performance assessments.
Our metrology services use calibrated equipment traceable to NIST standards. In adhering to NIST standards our teams can trace all parts of our medical device development projects through metrological measurements and ensure an unbroken line of measurements, tests and results.
Our traceable metrology services use calibrated equipment and include:
- Programmable Contact/Non-Contact Measurements
- Force Testing
- Pressure Testing
- Capability Studies
- Gauge R&R
- Analysis and Reporting
- First Article Inspection Reports
We’re going to briefly look at what these services are and how they help maintain the high standards of the medical device development process.
Programmable Contact/Non-Contact Measurements used in Metrology
These measurements employ linear displacement sensors to measure the distance between two points. Both contact and non-contact methods allow us to ensure all materials are the right shape and thickness. This information tells us whether or not materials are suitable for use and whether they can withstand the pressure of the required usage.
Tests are run on Europlaz’s Coordinate Measuring Machines. These machines measure within an accuracy of down to 3 microns, or about 25 times smaller than the diameter of a human hair. Additionally, our automated testing equipment can simulate thousands of cycles of operation to mimic everyday use and test the lifecycle of a product.
Force testing is a valuable tool to test how an object reacts to tensile or compressive loads. This can either be used to test regular usage or failure points. To test this, force testing involves several types of force including tension, flexing, compression, shear, and fracture. Within these tests, we also use a combination of dynamic and static loading.
Dynamic loading tests help determine the lifecycle of a material or device with sudden, consistent tests. By comparison, static testing applies force at a slower, more regular rate and is often used to find the breaking points of a material.
Static force testing is a highly valuable method for manufacturers such as ourselves to test for and comply with industry standards. Further to this, force testing can also highlight core issues or defects and allows us to get to the root cause before products have been manufactured or sent out to patients.
Pressure testing is similar to force testing and is used to determine breaking points as well as the potential for ruptures or bursting if the product or device stores fluid. These tests are thorough to ensure a quality product is developed with a reduced risk of leaking, breaking, or bursting.
In the manufacturing process for medical devices, there is a lot of data and variance. Capability studies examine the inherent variability of a process to account for any minor differences as a result of the machinery used or the measurement equipment used. This information is used to create process capability indices and ensure that products meet the strict demands of clients and organisations such as the FDA and ISO.
Gauge R&R is a valuable test for ensuring precision. As part of a complete measurement analysis system, gauge R&R looks at Repeatability and Reproducibility. To do this, a material or device is tested several times to see the variance in results. A low variance is desirable; if results do not meet our standards, the materials or system is investigated. As a result, gauge R&R is a great tool for process precision and detailed statistical analysis.
Analysis and Reporting
The industry-standard approach to validation is through dimensional measurement of the component using a robust validation strategy, supported by accurate, consistent and trustworthy measurements. The above tests and measurements provide a foundation for capability assessment and help inform other processes and departments such as the Quality Team.
First Article Inspection Reports
Finally, we also carry out first article inspection reports to ensure that the production line meets the required specifications. By doing so, we can ensure the system works before rolling out hundreds, if not thousands, of products. This report also ensures transparency and metrological traceability to provide added peace of mind.
Develop your medical device with Europlaz today
Metrology is just one facet of our complete turnkey solution. We specialise in designing and manufacturing the highest quality medical devices with applications across a wide spectrum of medical needs.
Our team is on hand to assist with every part of the process. We can manage all aspects from the specification of the tooling, prototyping, first samples, validation, production of batches for clinical trials, and final rollout. For more information contact us today.