Medical Device Complaint Handling: If you can’t stop the complaining, start the efficiency gaining.

Medical Device Complaint Handling: If you can’t stop the complaining, start the efficiency gaining.

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Complaints can come from anywhere; it’s what you do with them that matters.

And when it comes to reportable events, time is what matters most. The clock begins ticking the moment your organization becomes aware of a complaint. Having an easy-to-use, intuitive medical device complaint handling system can make all the difference when you need to quickly get information to the FDA CDRH or any other regulatory body. Your organization may never be able to fully eliminate complaints, but it can improve their handling.

How can you handle complaints efficiently and quickly?

The easy answer is to have an automated system in place with the built-in intelligence to drive consistent data, provide audit trails, and guide users to gather the right (and complete) information needed to determine its severity. Ideally, this system should include:

  • Complaint determination logic. Is this incident a true complaint? Is this truly related to your product? Is the information you’re receiving due to a product defect? Will it require creation of a CAPA, which may require additional steps?
  • Information carryover into downstream records. Do you have disparate complaint intake and quality management systems? Do you end up rekeying information reported from the field multiple times? Do you have to re-enter information into the regulatory report? Are you spending time manually entering information into the FDA’s e-Submitter tool?
  • Built-in regulatory reporting rules. Do you find the time is ticking away while your employees determine whether a regulatory report, such as a 5-day eMDR or 30-day eMDR is necessary? Do you have easy access to audit trails and proof of proper complaint investigation ready for inspectors?

Overcoming medical device complaint handling challenges

Did you answer ‘yes’ to any of those questions within the section above? Fear not; there’s a simple way to overcome these challenges and achieve better complaint handling efficiency.

An intuitive, closed-loop complaint management software solution as part of your overall quality management system, can give you the tools you need to consistently, effectively handle all incoming complaints and reportable events. To get the most from any solution, and work quickly against that ticking clock, you should look for capabilities such as:

  • Dynamic forms with built-in logic
  • Lookup tables for consistent data
  • Workflow / due date tracking
  • Editable decision trees
  • Audit trails
  • Configurable reports
  • Tracking and trending on any data field
  • Email alerts

Sounds great, but what about eMDR?

Beyond the challenges of medical device complaint handling, reporting serious complaints that are a potential hazard to the public to FDA CDRH comes with its own set of things to remember. An intelligent complaint handling solution can help. The right system will take the leg work out of preparing the eMDR files. It will automatically include case intake information, such as, when you became aware of the complaint, and it will properly format and error-check the XML file—which can make all the difference in getting your report accurately completed and submitted on time.

Want to see this in action?

You’re in luck; Pilgrim recently hosted a live demonstration of SmartSolve® Complaint Management, a solution which delivers all of the above capabilities, showcasing how the system handles eMDR requirements.


How SmartSolve Improves eMDR Submissions

On-Demand Recording

SmartSolve® Complaint Management helps you streamline complaint and regulatory reporting management. Download this product showcase video to learn how Complaint Management can help your organization.

medical device complaint handling



Adonna Blasko

Marketing Manager, Pilgrim Quality Solutions

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