Complaint Management for Devicemakers From Receiving and Investigating to Analyzing Trends
Complaint management is essential to a functioning quality management system.
Understanding the FDA’s Quality System Regulation isn’t enough — you must also master ISO 13485:2016 and the new EU MDR. They all require devicemakers to conduct trending in some form or another. But none of them tell you HOW.
This new edition of the best-selling Medical Device Complaint Management fills in that gap for you.
In addition to teaching the principles of successful complaint management …
Receiving, documenting and investigating complaints
Determining when complaints are reportable
Using complaints to update risk management data …
… the new report teaches you how to analyze trends in your complaint files to spot opportunities for product and program improvement.
The difference between a record and a report
Acceptable trend analysis methods (NEW)
How not to write yourself into a corner on complaint SOPs
The difference between complaint evaluation and complaint investigation
How to set up a complaint classification system (NEW)
How to use unique device identifiers, traceability control numbers and MDR event problem codes in trending (NEW)
Linking complaint analysis results to the risk management file
How international regulators view adverse event reporting, risk management and complaint classification (NEW)
It’s certain that your complaint management system will come under intense scrutiny in your next GMP inspection. Make sure you can show investigators not only how you have reacted to problems but also how you learn from them and use that information to drive continual improvement.
Don’t delay. Order Complaint Management for Devicemakers: From Receiving and Investigating to Analyzing Trends today.
Order Your Copy Today
PDF Edition — $397
Who Will Benefit
Regulatory affairs professionals
510K application specialists
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