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ISO 13485:2003 MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEMS

ISO 13485:2003 MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEMS

ISO 13485 is published in 2003 that represents the requirements of a comprehensive management system for the design and manufacture of medical devices.

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What is ISO 13485:2003 MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEMS?

Standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).

Primary Objective

  • The primary objective of ISO 13485 was to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard.
  • It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability.