From Receiving and Investigating to Analyzing Trends

FDAnews

Complaint Management for Devicemakers:

From Receiving and Investigating to Analyzing Trends

**An FDAnews Management Report**

http://www.fdanews.com/products/54565-complaint-management-for-devicemakers

It’s not enough to have a solid complaint handling system; regulators expect devicemakers to learn something from the feedback they receive.

The FDA’s Quality System Regulation, ISO 13485, ISO 14971 and the EU’s medical device regulations all require devicemakers to conduct trending in some form or another. But none of them tell manufacturers how.

This new edition of the best-selling Medical Device Complaint Management fills in that gap.

In addition to teaching the principles of successful complaint management the report covers:

  •     Receiving, documenting and investigating complaints
  •     Determining when complaints are reportable
  •     Using complaints to update risk management data

The new report teaches devicemakers how to analyze trends in complaint files to spot opportunities for product and program improvement.

New sections for 2017 include the following:

  •     Acceptable trend analysis methods
  •     How to set up a complaint classification system
  •     How to use unique device identifiers, traceability control numbers and MDR event problem codes in trending
  •     How international regulators view adverse event reporting, risk management and complaint classification

It’s certain that complaint management systems will come under intense scrutiny in GMP inspections. Manufacturers need to show investigators not only how they have reacted to problems but also how they learn from them and use that information to drive continual improvement.

Who Will Benefit:

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

FDAnews Management Report Details:

Complaint Management for Devicemakers:

From Receiving and Investigating to Analyzing Trends

**An FDAnews Management Report**

http://www.fdanews.com/products/54565-complaint-management-for-devicemakers

Price: $397

Easy Ways to Order:

Online:     http://www.fdanews.com/products/54565-complaint-management-for-devicemakers

By phone: 888-838-5578 or 703-538-7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

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