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Review
. 1997 Sep;8(7):12-5.

Complying with US and European complaint handling requirements

M E Donawa  1
Affiliations
  • PMID: 10174197
Review

Complying with US and European complaint handling requirements

M E Donawa. Med Device Technol. 1997 Sep.

Abstract

The importance of customer complaints for providing valuable information on the use of medical devices is clearly reflected in United States (US) and European quality system requirements for handling complaints. However, there are significant differences in US and European complaint handling requirements. This article will discuss those differences and methods for ensuring compliance.

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