1. 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. tstein@BPAconsultants.com 408-366-0848 May 10, 2011

2. Introduction to 62304 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 tstein@BPAconsultants.com 408-366-0848 2

3. May 10, 2011 Tim Stein tstein@BPAconsultants.com 408-366-0848 3 Structure of the Standard General requirements Software Development Process Software Maintenance Process Software Risk Management Process Software Configuration Management Process Software Problem Resolution Process

4. Software Development Process Planning Software requirement analysis Software architectural design Software detailed design May 10, 2011 Tim Stein tstein@BPAconsultants.com 408-366-0848 4

5. Software Development Process Software unit implementation and verification Software integration and integration testing Software system testing Software release May 10, 2011 Tim Stein tstein@BPAconsultants.com 408-366-0848 5

6. Documentation Verification Required Software requirements Software architecture Detailed designs Test procedures: unit, integration and system May 10, 2011 Tim Stein tstein@BPAconsultants.com 408-366-0848 6

7. 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 tstein@BPAconsultants.com 408-366-0848 7

8. 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 tstein@BPAconsultants.com 408-366-0848 8

9. Webinar – Compliance Online Aligning Medical Device Software Development with EU Require- ments for a CE Mark (IEC 62304) Tim Stein June 14, 2011 9:00 – 12:00 local time May 10, 2011 Tim Stein tstein@BPAconsultants.com 408-366-0848 9

10. Contact Information Tim Stein tstein@BPAconsultants.com 408-366-0848 www.BPAconsultants.com May 10, 2011 Tim Stein tstein@BPAconsultants.com 408-366-0848 10