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Essentials of ISO 13485:2003

About ISO 13485

ISO 13485 represents requirements for a comprehensive management system for the design and manufacture of medical devices.

BSI's Essentials of ISO 13485:2003

This one hour elearning course from BSI provides a comprehensive introduction to this standard. ISO 13485:2003 is explained clause-by-clause with examples from various industries to illustrate individual concepts. This online course provides a general understanding of the necessary concepts of the standard and its impact on day-to-day operations of organizations in the medical devices industry.

Learning Objectives

  • Understand the purpose and concepts of ISO 13485:2003
  • Know the requirements of the standard
  • Understand the rules for justified exclusions
  • Understand the process model
  • Learn the relationship between ISO 14971:2007 risk management and ISO 13485:2003
  • Understand how ISO 13485:2003 relates to regulatory requirements

Who Should Attend

Professionals who wish to learn about the ISO 13485:2003 standard, beginning at the introductory level.

System Requirements

  • Internet Explorer 7 and higher
  • Pop-up blockers should be deactivated when launching online courses
  • Flash
  • Adobe Acrobat Reader
  • Browser must be Java and JavaScript enabled

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