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EN ISO 62304: 2006 Medical Device Software Validation

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 for further information.

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