Nancy Singer founded Compliance-Alliance LLC to specialize in professional development for those employed in the drug and medical device industries. Previously she was the founder and the Executive Director of the Medical Technology Learning Institute, an educational entity within AdvaMed that provides training on FDA/CMS regulatory requirements. She also served as AdvaMed's Special Counsel for FDA compliance and enforcement matters. In her role as Special Counsel, Nancy was a member of the FDA/industry working group that evaluated and suggested reforms to the FDA inspectional process.

She then represented the industry on the working group that conceived and validated the procedures for the Quality System Inspection Technique (QSIT). She served as the industry spokesperson on the educational programs that taught QSIT to representatives of FDA and the medical device industry. For her efforts, she received Vice President Gore's Reinventing Government Hammer Award and the FDA Commissioner's Special Citation Award.
Nancy's email address is nancy@compliance-alliance.com

In 2005, FDA cited medical device firms for deficiencies in their complaint handling procedures more frequently than in any other area.

Many firms could improve their systems by comparing them with others. To help firms do this, Nancy Singer , Compliance-Alliance teamed up with Richard DeRisio of KCI. The survey asked about key elements in complaint handling procedures.

The survey had 30 questions , asking individuals to fill it out anonymously.

Below is a preliminary analysis of the results covering :

*  Demographic Information

*  Number of FTEs Processing Complaints

*  Interesting Insights

*  Commercial Software Applications

*  Motivating Customers and In-House Personnel to Report Complaints

*  Getting the Device Back From the Customer

*  Not Investigating Complaints

*  Goal for Closing Complaints