BPA 1 Verification in the Development of Medical Device Software Per IEC 62304 Tim Stein, Ph.D. CEO and President of Business Performance Associates, Inc.

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Presentation transcript:

BPA 1 Verification in the Development of Medical Device Software Per IEC Tim Stein, Ph.D. CEO and President of Business Performance Associates, Inc May 10, 2011

Introduction to IEC 62304:2006 Medical Device Software – Life Cycle Processes EU Medical Device Directive requires the development of SW using a state-of-the-art process Only FDA consensus standard for software development May 10, 2011 Tim Stein

May 10, 2011 Tim Stein Structure of the Standard General requirements Software Development Process Software Maintenance Process Software Risk Management Process Software Configuration Management Process Software Problem Resolution Process

Software Development Process Planning Software requirement analysis Software architectural design Software detailed design May 10, 2011 Tim Stein

Software Development Process Software unit implementation and verification Software integration and integration testing Software system testing Software release May 10, 2011 Tim Stein

Documentation Verification Required Software requirements Software architecture Detailed designs Test procedures: unit, integration and system May 10, 2011 Tim Stein

Verification / Testing Unit verification (Moderate and high risk) Establish strategies, methods and procedures for verifying each SW unit Integration testing, including regression testing System testing May 10, 2011 Tim Stein

Verification / Testing Verification of risk control measures Testing as part of change control New functionality Verify issue resolution Regression testing May 10, 2011 Tim Stein

Webinar – Compliance Online Aligning Medical Device Software Development with EU Require- ments for a CE Mark (IEC 62304) Tim Stein June 14, :00 – 12:00 local time May 10, 2011 Tim Stein

Contact Information Tim Stein May 10, 2011 Tim Stein