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Complaints Remediation to Meet FDA Consent Decree Deadline

An Open Letter to Medical Device Regulators

Addressing Consent Decrees

Learn how USDM enabled a global medical device company to address a Consent Decree and close out a complaints backlog of over 600,000 service orders. A sustainable process was developed to help the customer reduce the time it takes to process, code, and close out complaints.

The Situation
  • Global medical device company
  • Customer struggled to keep up with service orders and complaints
  • Customer needed help to close out complaints faster
  • Internal staff could not support Consent Decree timeline
  • Scope of project included processing more than 600,000 service orders
The Solution
  • USDM provided a team of 36 consultants with USDM leadership to develop a sustainable process for handling service orders and complaints
  • USDM applied its domain expertise to quickly address the customer’s backlog of 600,000 service orders
  • USDM helped customer reduce its time to process and close out complaints

The Results

  • Customer achieved FDA Consent Decree deadlines and remediation​
  • Customer uses best practices to manage complaints
  • Customer now has a more efficient complaint handling process

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

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