Tensentric
Engineering and manufacturing services for medical devices, in‑vitro diagnostics, life sciences instruments, and cell & gene therapy systems. Offers end‑to‑end product development from Phase Zero concept and human factors through design, validation, New Product Introduction (NPI) and low-to-medium volume manufacturing under an ISO 13485 quality system.
Industries
Nr. of Employees
small (1-50)
Tensentric
Patents
Systems, methods, and devices for automated nucleic acid and protein isolation
US-11994528-B2
View Details
Systems, methods, and devices for automated nucleic acid and protein isolation
US-11994528-B2
View DetailsProducts
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.
Services
User research, risk analysis, formative and summative usability testing to produce HFE deliverables for regulatory submissions.
Cross‑disciplinary product development including Phase Zero risk reduction, industrial design, mechanical/electrical engineering and prototyping under design controls.
Secure product development, threat modeling, security requirement creation and secure firmware practices for regulated devices.
Controlled production runs, line validation, cleanroom assembly and ramp‑to‑volume manufacturing in a facility operating under ISO 13485.
In‑house biochemical testing, assay prototyping and high‑fidelity integration testing to reduce assay‑instrument interface risk.
Interdisciplinary design to meet reliability, EMC and test requirements, plus custom assembly and test fixture development for verification.
User research, risk analysis, formative and summative usability testing to produce HFE deliverables for regulatory submissions.
Cross‑disciplinary product development including Phase Zero risk reduction, industrial design, mechanical/electrical engineering and prototyping under design controls.
Secure product development, threat modeling, security requirement creation and secure firmware practices for regulated devices.
Controlled production runs, line validation, cleanroom assembly and ramp‑to‑volume manufacturing in a facility operating under ISO 13485.
In‑house biochemical testing, assay prototyping and high‑fidelity integration testing to reduce assay‑instrument interface risk.
Interdisciplinary design to meet reliability, EMC and test requirements, plus custom assembly and test fixture development for verification.
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
News & Updates
Industry networking event hosted at company office focused on advanced therapies.
Article describing sterilization considerations for complex medical consumables and materials interactions.
Overview of human factors engineering importance for medical devices and IVD systems.
Company operates under an ISO 13485 quality management system (certificate available online).
Announcement of new manufacturing facility to support NPI and volume manufacturing.
Industry networking event hosted at company office focused on advanced therapies.
Article describing sterilization considerations for complex medical consumables and materials interactions.
Overview of human factors engineering importance for medical devices and IVD systems.
Company operates under an ISO 13485 quality management system (certificate available online).
Announcement of new manufacturing facility to support NPI and volume manufacturing.