The topic of software validation is one that continues to cause confusion, so we have developed a series of flowcharts to help clarify the requirements. These cover:
* EN ISO 62304; 2006 medical device software – software life cycle processes
* FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff
Please contact Farhaan Shaikh on +44 (0)1926 800153 or via email to firstname.lastname@example.org for further information.