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ISO 13485: medical devices - quality management systems - requirements for regulatory purposes

ISO 13485: medical devices - quality management systems - requirements for regulatory purposes

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ISO 13485 (medical devices-quality management systems-requirements for regulatory purposes) is an international standard that presents the requirements for a quality management system specific for the realization of medical devices, including software systems with medical purposes. For the reminder of the chapter, we will refer to ISO 13485:2016, which is the latest available version of the standard.

Chapter Contents:

  • 5.1 Introduction
  • 5.2 Contents
  • 5.2.1 The Quality Management System
  • 5.2.2 Management responsibility
  • 5.2.3 Resource management
  • 5.2.4 Product realization
  • 5.2.5 Measurement, analysis, and improvement
  • 5.3 ISO 13485: 2016 versus other Quality Systems
  • 5.4 ISO 13485 certification
  • 5.5 Use of ISO 13485 in each jurisdiction

Inspec keywords: ISO standards; biomedical equipment; quality management

Other keywords: software systems; ISO 13485; medical devices-quality management systems-requirements; ISO 13485:2016; international standard; regulatory purposes

Subjects: Inspection and quality control; Standards and calibration

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