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
The Results
- FDA Consent Decree deadlines and remediation achieved
- Customer trained on complaints handling best practices
- More efficient complaint handling process implemented
Download the Complaint and CAPA Management
solution overview to learn more:
