A company was developing a new device, but they did not have a design and development workflow in place. Sequence Group came in and compiled the entire Design History File for the device and oversaw the product development. At the completion of the design, Sequence Group compiled the device’s 510k and oversaw the regulatory approval process.
New Medical Device Product Development
Case details
Location:
Boca Raton, Fl
Started
May 10, 2017
Completed:
February, 2018
Category:
Consumer Products
What client say
«Sequence Group's regulatory consulting guidance was a tremendous help during the initial growth phase of our organization.»
Larry Johnson
Founder«Sequence Group was vital in providing guidance and support during the design and development process that led the successful deployment of our device to market.»
David S. Thomas
Director of R&DThe challenge the company encountered was they did not have the in -house expertise to develop a complete Design History File or compile a submission to the FDA.
Problems Vs Solutions
Sequence Group developed the entire Design History File by working in close collaboration with the engineering and contracting teams. Once the device was complete and validation was finalized, Sequence Group began the regulatory approval process.
The device was cleared for regulatory approval on the US market.
