Outsource Your Complaint and Adverse Event Management

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.

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.

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.

During 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 presents 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.

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

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.

Let USDM help your organization manage complaints and adverse events—contact us today. 

0

0