Does your software development life cycle employ industry best practices? Will your design history file contents be correct and of the quality needed for FDA submission? How do you know?
Assessments are powerful business tools that can identify the current state of what is being assessed and identify opportunities for improvement. Assessments can be performed on many aspects of a software project, ranging from measuring a project’s success to evaluating the quality of a specific project deliverable.
The RND Group has worked with the leading companies in the medical device industry since 1997. The RND Group fully understands the rigor required in designing, developing, documenting, and testing products that are regulated by the FDA. The RND Group has applied that rigor to the software engineering support it has provided for countless product development efforts, and The RND Group can point with pride to products that have been successfully introduced into the medical device marketplace.