At Stress Engineering Services, we provide comprehensive testing services for a broad range of medical devices, including drug delivery or combination devices, surgical tools, implantable devices, diagnostic tools, and more. Our expertise in developing custom test equipment, plus our vast experience in testing and analyzing plastic products, explains why we are the ideal choice for both complex verification and standardized testing.
Our testing and development team members work closely with clients to define effective test protocols that will accurately assess product behavior and provide the data needed for regulatory requirements. Our extensive materials expertise, along with broad-based design history, gives us a distinct advantage in product testing, which translates into better results for our clients.
Verification testing provides the necessary evidence to demonstrate the safety and effectiveness of your medical device, a vital component of the regulatory clearance or approval process. Our team is equipped with the experience, equipment, and quality system to support our clients throughout the entire verification process, from method development, test protocol generation, test method validation, test execution, and reporting, while maintaining sample traceability and cGDP.
ISO 9001:2015 & ISO 13485:2016 Certified
ISTA Certified Laboratory
Licensed for Laboratory Testing and Research on Drug Products
Our focus is not only to help make your product function, but we want your customer to gain the maximum benefit from its use. Our laboratory studies include assessment of human factors, user interactions and ergonomics. In addition to the product “feel”, we provide measured data on forces, displacements, acceleration, vibration, temperature, and other factors that affect product function and how the user perceives it. As always, the emphasis is to provide actionable data that can be used by marketing, research, development, engineering, and manufacturing to produce and market a superior product.
Critical life assessment testing of new medical/surgical products and sub-systems is a cornerstone of our development services. These tests often involve aging studies and repeated physical loads, such as multiple firing or clamping operations during use, or harsh environmental effects like sterilization. The objective of this testing is to develop reliability data for the components, sub-systems or devices in order to address product requirements and support warranty specifications.
Reliability testing can be completed at the client’s site or in Stress Engineering’s medical and pharmaceutical device testing lab. Our is certified to ISO 9001:2015 for design. We have experience with the design, planning, and analysis of a variety of tests:
We provide laboratory testing services to measure material property data including chemistry, static tensile, creep, fatigue and other types of data that are needed to design and validate medical products. This data can be used to predict product performance before components are manufactured, thus helping to identify design problems early in the product development process, when design changes are more easily made. Our material testing services are closely integrated with our predictive engineering group so the right test data are available and in a form that can be easily used for design calculations.
If you would like more information on Stress Engineering Services, please call us at 281.955.2900, or complete the following form and one of our representatives contact you shortly. For a complete listing of contact information, visit our Locations page.