ISO 14971 For Medical Device Risk Management

Rami.Azulay February 23rd, 2011 Posted by Rami Azulay( ) ISO 14971, Standards and Regulations

ISO 14971 represents the requirements for a medical device risk management system.

This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality standards such as ISO 13485.

ISO 9000 Quality Standards

  • ISO 9001:  Design and Manufacturing
  • ISO 9002:   Manufacturing Only
  • ISO 9003:  Inspection and Testing Only


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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