Learn the concepts of QMS software validation, how to assess risks related to QMS software and how to apply IQ, OQ and PQ to QMS software.
ISO 13485:2016 introduced requirement #4.1.6 on validation of software used in QMS process. Given the complexity of software design, companies and managers expect hard times when they come to apply classical validation methods to software. Software has its own rules and concepts: failure, bugs, defects and user errors. These concepts and the way to handle them have a significant influence on the validation process. Knowing how to combine ISO 13485:2016 QMS software validation with activities of software development, installation, configuration and maintenance is the key factor to your success in the software medical device industry.
People working for medical devices or in vitro diagnosis manufacturers:
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