Socrates Development LLC

socrates development llc socrates development is a consulting firm that assists clients in using best practices for medical product development. recently socrates has focused on helping clients upgrade their legacy design history files to be compliant with the fda’s case for quality initiative. this work uses design for six sigma (dfss) tools such as critical parameter management to identify critical to quality attributes that are most important to the fda. this helps clients focus limited resources on those items that are most critical to safety and efficacy. other consulting services include: • capa investigation • continuous improvement coaching • design of experiments • meeting facilitation • system engineering • system verification • intellectual property analysis • review of designs to identify design flaws early in the development process • creation of statistical models to predict product performance • new product ideation client technologies to date include: • cancer therapeut