Our client had “Proof of Concept” level software with no established design controls. The software was needed for critical beta/clinical trial timeline. Our client’s success was dependent on meeting milestones with quality software.
RND took over all aspects of the software including communications and firmware. RND established a design history file, configuration control, and a plan to meet the customer’s milestones. RND is currently meeting those milestones.
FDA Part 820, Part 11
ISO 13485 Quality System
WPF UI Design/Development
C#, WPF Development