Put qualified post-market surveillance specialists, investigators, engineers, and clinicians to work for you.
Failing to investigate and process complaints and adverse events can lead to regulatory citations. Further, regulatory authorities have the right to delay products and shut down businesses that don’t have sufficient post-market surveillance (PMS) practices in place.
In Short
- Backlogged or under-resourced complaint and adverse event programs expose life sciences companies to regulatory citations, product delays, and business interruption.
- Outsourcing brings in experienced post-market surveillance specialists, investigators, engineers, and clinicians without pulling your in-house experts off value-added work.
- USDM staffs, onboards, and manages the team with a customer-approved team lead, agreed-upon metrics, weekly reporting, and a right-fit guarantee.
- The same rigor extends to CAPA, medical device incident reporting, and EU MDR recoding—supported by sound data integrity and validated systems.
What You Learn from Best Practices
There are best practices to help get your complaint and adverse event program in place and functioning as needed. One important aspect of these best practices is to determine the volume of activity in your program and how long it takes to process complaints and adverse events. How many employees does your company have—or how many does it need based on volume—for efficient and effective reporting?
If your company has resorted to pulling in-house experts away from their value-added work on other projects, then it’s time to investigate outsourcing. It’s an ideal solution that brings in experienced, trusted professionals to support your internal team.
USDM Life Sciences has more than 20 years of experience in the life sciences industry and recruits top-level consultants to augment your in-house teams. You’ll work with qualified professionals whose expertise in post-market surveillance enables rapid complaint and adverse event resolution.
Why speed matters: Regulatory authorities can delay products or halt operations when post-market surveillance lags. Strong complaint analytics depend on trustworthy records—see how data integrity in life sciences underpins defensible complaint and adverse event decisions.
How it Works
When you augment your in-house teams with these qualified professionals, you’re able to maintain consistent quality management procedures, investigate complaints properly, and report adverse events promptly.
The USDM Consulting Process
- The client services director considers your project needs and helps determine the number of consultants required.
- Recruiters find candidates through USDM’s extensive network and referral program, then present qualified consultants for customer review.
- USDM handles orientation and training logistics to help ensure speedy and efficient onboarding.
- Service fulfillment includes a consultant integration period and a one-week right-fit guarantee.
Whether the team is working on-site or remotely:
- USDM staffs the team with qualified post-market surveillance specialists, investigators, engineers, and clinicians. A team lead pre-approved by the customer is also assigned.
- The USDM team lead works with your organization to develop metrics.
- The USDM team lead assigns work to the team and conducts daily meetings with your organization to review progress.
- Weekly reports are generated to show performance against agreed-upon metrics.
- Weekly meetings are held with the entire team.
Outsourcing post-market surveillance isn’t just about adding headcount—it’s about restoring a repeatable, audit-ready process that keeps complaints and adverse events moving.
Download our CAPA and Complaint Handling datasheet to learn more.
Why Choose USDM Life Sciences
USDM focuses exclusively on life sciences and global regulatory compliance. We’ve provided successful compliance solutions to biotech, pharmaceutical, and medical device companies.
USDM complaint handling services include, but are not limited to:
- Coding, processing, and investigating complaints and adverse events
- Analyzing complaint data to initiate corrective and preventive action (CAPA)
- Identifying the root cause and developing corrective actions
- Conducting medical device incident reporting
- Recoding complaints and adverse events to address EU MDR requirements
Because complaint and adverse event programs run on validated systems and electronic records, the right outsourcing partner also brings discipline in computer software assurance (CSA) and 21 CFR Part 11 compliance—keeping the software and records behind your PMS program inspection-ready. And when surveillance work is performed by external consultants and connected systems, a structured approach to third-party risk management helps protect quality and data along the way.
Who We’ve Helped
A global medical device company was struggling to keep up with a backlog of more than 600,000 service orders and they needed help to close out complaints faster. The internal team could not support a U.S. Food and Drug Administration (FDA) consent decree. USDM assembled a team of 36 consultants and developed a sustainable process for handling service orders and complaints. The customer achieved successful remediation and met FDA consent decree deadlines. They now incorporate best practices and have an efficient complaint handling process.
A large medical device manufacturer with products in multiple countries needed to get existing devices recertified according to the European Union Medical Device Regulation (EU MDR). Requirements included new post-marketing safety analysis and reporting, and the manufacturer needed to plan for recalls by item. Among its solutions, the USDM team of consultants inventoried policies and procedures affected by the EU MDR, reviewed their proposed revisions with regulatory and quality managers, and established a quality system to meet EU MDR requirements.
For organizations running these programs on cloud and SaaS quality systems, USDM Cloud Assurance keeps those validated systems continuously compliant as vendors push updates—so your complaint and adverse event workflows stay inspection-ready.
FAQ: Outsourcing Complaint and Adverse Event Management
When should a company consider outsourcing complaint and adverse event management?
When complaint and adverse event volume outpaces your team’s capacity—or you find yourself pulling in-house experts away from value-added work—outsourcing brings in experienced, trusted professionals to support your internal team and keep reporting efficient and effective.
What roles does USDM provide for post-market surveillance?
USDM staffs teams with qualified post-market surveillance specialists, investigators, engineers, and clinicians, plus a team lead pre-approved by the customer who develops metrics, assigns work, and reviews progress.
What complaint handling services does USDM offer?
Services include coding, processing, and investigating complaints and adverse events; analyzing complaint data to initiate CAPA; identifying root cause and developing corrective actions; medical device incident reporting; and recoding complaints and adverse events to address EU MDR requirements.
What are the risks of inadequate post-market surveillance?
Failing to investigate and process complaints and adverse events can lead to regulatory citations. Regulatory authorities also have the right to delay products and shut down businesses that don’t have sufficient post-market surveillance practices in place.
How does USDM ensure the right team fit?
USDM recruits candidates through its network and referral program, presents qualified consultants for customer review, handles orientation and training logistics, and backs fulfillment with a consultant integration period and a one-week right-fit guarantee.
Get Started
Let USDM help your organization manage complaints and adverse events—contact us today to put qualified post-market surveillance specialists to work for your team.