IVD System Development: Don’t Forget the Assay
Iterating product design while keeping biochemical system interfaces at the forefront de-risks key technical challenges earlier and accelerates device development.
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.
UX/HF Training Courses
Tensentric offers an entire series of training courses on user experience and human factors (UX/HF) specifically tailored for medical device and in-vitro diagnostics systems. Courses for 2020 include: (1) Human Factors Testing for Medical Devices – Requirements and Best Practices and (2) Meeting Human Factors Requirements for MDR and IVDR. We also offer UX/HF training to our clients as part of projects that we’re engaged on.
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
Formative Usability Testing in Medical Device Development
Imagine a medical device development team has done preliminary analyses on who will be using the device.
Microsoft Blazor: Finally, a Cross-Platform GUI Solution for Medical Devices
Every product development effort containing embedded software must answer the question early on “Which operating system should the device run?”
Our Clients Include...
