Put qualified post-market surveillance specialists, investigators, engineers, and clinicians to work for you.
For medical device companies, inconsistent quality management procedures and failure to properly 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 practices in place.
There are best practices to help get your complaint and adverse event program in place and functioning as needed. They start with defining your current situation, then delve into data migration efforts when implementing a new system, analyzing the data elements required for your system, and automating the intake of complaints and adverse events.
Establishing and maintaining systems and practices takes a lot of time and effort. It might also require you to pull your in-house experts away from their value-added work in other areas. However, outsourcing your complaint and adverse event processing, reporting, and analytics allows you to bring in experienced, trusted professionals to support your internal team. When you rely on USDM Life Sciences to augment your in-house teams, you’ll work with qualified post-market surveillance professionals whose expertise is driving rapid complaint and adverse event resolution.
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
Why choose USDM Life Sciences
USDM focuses exclusively on life sciences and global regulatory compliance and we’ve provided successful compliance solutions to biotech, pharmaceutical, and medical device companies for more than 20 years. Our experts have deep industry knowledge and experience that saves you significant time and money.
Learn more about USDM’s life sciences expertise that helps you create a competitive advantage. Read this case study to discover how we enabled a global medical device company to address a Consent Decree, close out a complaints backlog of over 600,000 service orders, and develop a sustainable process that reduced the timeline to process, code, and close out complaints.
Let USDM help you manage complaints and adverse events—call (888) 231-0816 or contact us here.