Many cell and gene therapy products require highly specialized devices for manufacturing, storage, transportation, and/or delivery. Our device engineers design a customized device solution that meets the unique needs of your product. We assist you with manufacturing and regulatory support for implementation of your device solution.
URS development:
Working with your team, we define the specific user requirement specification (URS) for your required device solution.
Landscape scan and gap analysis:
Once a URS is defined, we evaluate the landscape of available devices to determine if an existing solution can meet your needs.
Custom device design:
If an existing device does not exist that can meet your requirements, our device engineers design one for you.
Contract manufacturing management:
Once a concept design is developed, our team leads Request For Quotation (RFQ) authorship, engineering firm selection, and project management oversight of prototype and final device manufacturing.
Regulatory documentation:
We assist you in authorship of Design History File(s) (DHFs), Device Master Files (DMFs), and any other required documentation for your device.
Many cell and gene therapy products require highly specialized devices for manufacturing, storage, transportation, and/or delivery. Our device engineers design a customized device solution that meets the unique needs of your product. We assist you with manufacturing and regulatory support for implementation of your customized device solution.
URS development:
Working with your team, we define the specific user requirement specification (URS) for your required device solution.
Landscape scan and gap analysis:
Once a URS is defined, we evaluate the landscape of available devices to determine if an existing solution can meet your needs.
Custom device design:
If an existing device does not exist that can meet your requirements, our device engineers design one for you.
Contract manufacturing management:
Once a concept design is developed, our team leads Request For Quotation (RFQ) authorship, engineering firm selection, and project management oversight of prototype and final device manufacturing.
Regulatory documentation:
We assist you in authorship of Design History File(s (DHFs), Device Master Files (DMFs), and any other required documentation for your device.