Arthroscopy Console
Services Provided
Program / Project Management
Risk Management
Systems Engineering
Usability Engineering
Software Quality
Electrical Product Safety
Client Background:
This client had a successful and profitable predicate device; however, it required aesthetic and technical updates to extend its commercial life. In undertaking this work, the client hoped to avoid a perception of product obsolescence while defending the brand’s leading position within the market.
Client’s Request(s):
The client asked us to develop and deliver a refreshed product that would preserve compatibility with all accompanying (20+) legacy handpieces used with this console, implement several key technological features to refresh the look & feel of the product and improve the overall usability of the device.
Project Actions:
Our staff managed the project, leading and supporting 30+ key functional roles integral to the project. We also contributed significantly to the Systems Design phase.
We managed the client’s staff accordingly, to complete all electrical, software, and engineering work.
Concise Engineering performed all required Risk Management, Usability Testing, and helped manage the Software Quality team’s workload.
Outcome:
The product successfully cleared 510(k) via our team members’ direct support.