Beyond Usability: Designing CLIA Waived Devices
Tensentric’s team is equipped to support CLIA waived device design efforts with years of experience designing simple and accurate devices that meet the waived test criteria set forth by the FDA.
When you're choosing a partner to design and manufacture your medical device or in-vitro diagnostics system, you can’t afford to have any doubts.
Services
Turn-key System Design from Initial Concept through Volume Manufacturing
Tensentric’s team averages over 20 years of engineering experience and are highly skilled in all aspects of complex system design. From early concept development and ideation, through detailed design and prototyping, developing and manufacturing saleable medical devices and in-vitro diagnostics is Tensentric’s core competency. We’re ISO13485-2016 certified for both design development and manufacturing and have successfully completed over 125 development projects since the company’s inception in 2009.
Technical Assessments
Many of our clients and investors have leveraged our many decades of medical device and in-vitro diagnostics system design experience to perform technical assessments of potential acquisitions and for independent third-party evaluations. We’re happy to share our expertise and offer this as a dedicated service.
Human Factors Engineering Services
Our best in class Human Factors Engineering (HFE) services help you optimize the usability and use-safety of your products. Our services include user research, risk analysis, user interface design and rapid prototyping, usability testing with full COVID-19 precautions as well as human factors studies requiring BSL-1 or BSL-2 laboratory facilities.
Volume Manufacturing
Tensentric has recently extended our service offering to carry our designs into volume manufacturing of finished products. Focused primarily on high level assembly of highly complex systems during the initial NPI phase or ramp-to-volume, we have a dedicated manufacturing facility of 12,000 square feet with all necessary equipment and fixtures including an ISO certified clean room.
Experience
Thinking
Medical Packaging Design: Thinking Outside the Box
Packaging design is an integral part of a new or existing product. Check out our latest whitepaper outlining design considerations for medical device packaging to ensure your product is delivered safely and effectively.
The Art of Usability Test Moderation
With some hands-on practice, tips and guidance, you can master this art and science of moderation and ensure the data from your usability test is high-quality.
Our Clients Include...
