Qualified Post Market Surveillance professionals to augment your in-house teams and drive rapid complaint resolution

For medical device companies, managing complaints and adverse events is critical. Inconsistent quality management procedures and failure to properly investigate complaints and adverse events can lead to regulatory citations. At USDM Life Sciences, you can outsource your entire complaint and adverse event processing, reporting and analytics needs. We provide experienced, trusted professionals to work on-site or remotely to support your internal team.
 
USDM Services
  • Receive, enter, code, process, and investigate complaints and adverse events
  • Recoding complaints and adverse events to address new EU MDR requirements
  • Triage in-bound complaints to determine severity and potential adverse event reporting requirements
  • Investigate and analyze complaint data and/or gather additional data and initiate CAPAs as needed
  • Disseminating complaint and adverse event data/information to relevant internal teams
  • Medical Device Incident Reporting
  • Address Agency findings quickly
 
Need remediation or CAPA assistance? USDM can help now! Email or call us at 1.888.231.0816.
 
Benefits of USDM
  • Immediate capability to staff or fill in the gaps with complaint handling and safety reporting teams
  • On-site and remote capabilities to meet your unique needs
  • Adaptable staffing models with individuals or managed teams
  • Proven ability to solve your urgent complaint and adverse event problems
  • Ensure the continuity of your regulated processes
  • Meet your regulatory reporting requirements
  • Tackle peak workloads or clear backlogs
  • Improve your processes to streamline or reduce future complaints
 
Learn how USDM helped a global medical device company 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 in this recent case study.
 
How it Works
  • USDM assigns team lead that is pre-approved by customer
  • USDM staffs the team of qualified post market specialists, investigators, and clinicians
  • The USDM team lead works with the customer to develop metrics
  • The USDM team lead assigns and reviews work to team
  • Daily meetings between team lead and team keep everyone updated on progress
  • Weekly team meetings drive further progress and communication with customer
  • Weekly reporting is sent to the customer to show performance against agreed upon metrics
 
Why USDM
  • 20+ years providing compliance solutions
  • Subject Matter Experts – Former FDA authorities and life science experts with deep industry knowledge
  • Exclusive focus on life sciences and global regulatory compliance
  • Significant time savings by providing the right industry resources
  • Flexible and adaptable solutions for regulated businesses
 
Read our blog on Best Practices for Complaint and Adverse Event System Implementation.

 
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Leading experts in every Life Sciences field.

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