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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

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Title: The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
Author: Kimberly A. Trautman
ISBN: 0873893778 / 9780873893770
Format: Hard Cover
Pages: 210
Publisher: ASQ
Year: 1997
Availability: Out of Stock
     
 
  • Contents

Introduction
Comparison Chart

Subpart A : General Provisions
Subpart B : Quality System Requirements
Subpart C : Design Controls
Subpart D : Document Controls
Subpart E : Purchasing Controls
Subpart F : Identification and Traceability
Subpart G : Production and Process Controls
Subpart H : Acceptance Activities
Subpart I : Nonconforming Product
Subpart J : Corrective and Preventive Action
Subpart K : Labeling and Packaging Control
Subpart L : Handling, Storage, Distribution, and Installation
Subpart M : Records
Subpart N : Servicing
Subpart O : Statistical Techniques

Index

 
 
 
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