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Regulatory environment and government impact on the quality of dialysis products

  • Steven Hoff
  • Richard Newman
Part of the Developments in Nephrology book series (DINE, volume 39)

Abstract

Governmental efforts to regulate renal dialysis product manufacturers focuses on three general areas: product registration, regulatory inspections and postapproval surveillance. Product registration is commonly associated with regulatory submissions to the various governmental agencies, where the quality of product design, performance, clinical studies and other information are used to establish the safety and effectiveness of those products. Regulatory inspections help drive the quality of processes within the industry and the overall quality systems and implementation of the good manufacturing practices (GMPs). Post-approval surveillance provides the long-term quality impact on the industry by requiring industry to understand the performance and reliability of their products in the end-user’s hands.

Keywords

Medical Device European Economic Area Medicine Approval Application Product Registration Medical Device Regulation 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Kluwer Academic Publishers 1999

Authors and Affiliations

  • Steven Hoff
  • Richard Newman

There are no affiliations available

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