Complaint Management for Devicemakers: From Receiving and Investigating to Analyzing Trends

$397.00
Quantity Discounts
1 - 2
$397.00
3 - 4
$357.00
5 - 6
$337.00
7 - 9
$317.00
10 - 9999
$297.00

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.

You’ll learn:

  • 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

 

Available Format

PDF Edition — $397

Who Will Benefit

  • Compliance personnel
  • Regulatory affairs professionals
  • QA/QC personnel
  • Manufacturing executives
  • 510K application specialists

Multi-user Access

Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.

Our Guarantee

Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.