Verification in the Development of Medical Device Software Per IEC 62304

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_at_BPAconsultants.com 408-366-0848
• May 10, 2011

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Introduction to 62304

• IEC 623042006 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

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

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Software Development Process

• Software unit implementation and verification
• Software integration and integration testing
• Software system testing
• Software release

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Documentation Verification Required

• Software requirements
• Software architecture
• Detailed designs
• Test procedures unit, integration and system

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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

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Verification / Testing

• Verification of risk control measures
• Testing as part of change control
• New functionality
• Verify issue resolution
• Regression testing

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• Webinar Compliance Online
• Aligning Medical Device Software Development with
  EU Require-ments for a CE Mark (IEC 62304)
• Tim Stein
• June 14, 2011
• 900 1200 local time

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Contact Information

• Tim Stein
• tstein_at_BPAconsultants.com
• 408-366-0848
• www.BPAconsultants.com