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Complaints Remediation to Meet FDA Consent Decree Deadline

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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:

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