Tensentric
Tensentric is a contract design and manufacturing firm focused solely on medical device, in vitro diagnostic, and advanced therapy markets. We're ISO13485 certified and FDA registered to help our clients bring their new technology and products to market.
Industries
Nr. of Employees
small (1-50)
Tensentric
2900 Center Green Court Boulder, CO 80301
Products
Turn-key System Design
Tensentric offers comprehensive system design services from initial concept through volume manufacturing, including prototyping and NPI.
Human Factors Engineering
Provides human factors engineering to optimize product usability and safety, ensuring compliance with US and OUS standards.
Custom Engineered Instruments and Consumables
Specializes in the development of custom engineered instruments and consumables for medical applications.
Manufacturing of Finished Products
Facilitates the manufacturing of finished products with a focus on complex system assembly during NPI and volume ramp-up.
Regulatory Compliance Support
Assists clients in meeting regulatory constraints for various medical devices and systems, ensuring safety and effectiveness.
Agile Product Development Under Design Controls
Utilizes a hybrid Agile development process tailored for medical device development, emphasizing rapid and efficient product realization.
Turn-key System Design
Tensentric offers comprehensive system design services from initial concept through volume manufacturing, including prototyping and NPI.
Human Factors Engineering
Provides human factors engineering to optimize product usability and safety, ensuring compliance with US and OUS standards.
Custom Engineered Instruments and Consumables
Specializes in the development of custom engineered instruments and consumables for medical applications.
Manufacturing of Finished Products
Facilitates the manufacturing of finished products with a focus on complex system assembly during NPI and volume ramp-up.
Regulatory Compliance Support
Assists clients in meeting regulatory constraints for various medical devices and systems, ensuring safety and effectiveness.
Agile Product Development Under Design Controls
Utilizes a hybrid Agile development process tailored for medical device development, emphasizing rapid and efficient product realization.
Expertise Areas
- Medical device product development
- In‑vitro diagnostic instrument and consumable development
- Cell and gene therapy bioprocessing automation and scale‑up
- Human factors engineering and usability
Key Technologies
- Fluidics and liquid handling
- Optics and fluorescence detection
- Embedded software and firmware
- Human factors / UX research methods