Addressing Consent Decrees

Learn how USDM enabled a large, global medical device company to address a Consent Decree and closeout a complaints backlog of over 600,000 service orders as well as develop a sustainable process that reduced the timeline to process, code, and closeout complaints.

The Situation
  • Large, global, medical device company
  • Customer struggling to keep up with service orders and complaints
  • Customer needed help reducing timeline for closure of complaints
  • Internal staff could not support Consent Decree timeline
  • Scope of project included processing ~600,000 service orders
The Solution
  • USDM’s provided a team of 36 consultants with USDM leadership to accelerate development of a new process for handling service orders and complaints
  • USDM utilized their domain expertise to quickly address the customer’s backlog of 600k service orders
  • USDM’s trained customer on best practices to manage complaints to address the immediate need and developed a sustainable process for customer to maintain on their own in the future
  • USDM met all customer deadlines for FDA submission and required completion date
  • USDM helped customer maintain and reduce its time for complaint processing and closure
  • Customer is now managing complains within a reduced time from receipt to closure

​Download the Complaint and CAPA Management
solution overview to learn more:

FDA Consent Decree deadlines and remediation achieved

Customer trained on complaints handling best practices

More efficient complaint handling process implemented

We use cookies to understand how you use our site and improve your experience. This includes personalizing content and advertising. Learn more.