USDM's post-market surveillance professionals can augment your in-house teams and drive rapid complaint resolution.

For medical device companies, inconsistent quality management procedures and failure to properly investigate complaints and adverse events can lead to regulatory citations. With 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.

Building a Successful CAPA Process

When you need knowledgeable and experienced professionals for your corrective and preventive actions (CAPA) processes, USDM can provide team members to help you create processes for:

  • Receiving, entering, coding, processing, and investigating complaints and adverse events
  • Recoding complaints and adverse events to address new EU MDR requirements
  • Triaging in-bound complaints to determine severity and potential adverse event reporting requirements
  • Investigating and analyzing complaint data and gathering additional data and initiating CAPAs as needed
  • Disseminating complaint and adverse event data to relevant internal teams
  • Addressing agency findings quickly
  • Managing medical device incident reporting

Benefits of USDM’s adaptable staffing models include:

  • 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
  • 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 reduce future complaints

In this case study, learn how USDM helped a global medical device company address a Consent Decree and close out a complaints backlog of over 600,000 service orders, as well as develop a sustainable process that reduced the timeline to process, code, and close out complaints.

How Our CAPA Implementation System Works

USDM is ready to apply proven methods to meet your needs. We’ll start by:

Communication includes:

  • Daily meetings between the team lead and team
  • Weekly team meetings to drive further progress and communication
  • Weekly reporting to show performance against agreed upon metrics

USDM's CAPA Process Expertise

Why choose USDM?

  • 20+ years providing compliance solutions
  • Subject matter experts (SMEs) include former U.S. Food and Drug Administration (FDA) authorities and life sciences 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
Thought Leaders

Leading experts in every Life Sciences field.

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