BPA 1 Verification in the Development of Medical Device Software Per IEC 62304 Tim Stein, Ph.D. CEO...
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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. [email protected] 408-366- 0848 May 10, 2011
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Transcript of BPA 1 Verification in the Development of Medical Device Software Per IEC 62304 Tim Stein, Ph.D. CEO...
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.
[email protected] 408-366-0848
May 10, 2011
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 [email protected] 408-366-0848 2
May 10, 2011 Tim Stein [email protected] 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
Software Development Process
Planning Software requirement analysis Software architectural design Software detailed design
May 10, 2011 Tim Stein [email protected] 408-366-0848 4
Software Development Process
Software unit implementation and verification
Software integration and integration testing
Software system testing Software release
May 10, 2011 Tim Stein [email protected] 408-366-0848 5
Documentation Verification Required
Software requirements Software architecture Detailed designs Test procedures: unit, integration
and system
May 10, 2011 Tim Stein [email protected] 408-366-0848 6
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 [email protected] 408-366-0848 7
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 [email protected] 408-366-0848 8
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 [email protected] 408-366-0848 9
Contact Information
Tim Stein
408-366-0848
www.BPAconsultants.com
May 10, 2011 Tim Stein [email protected] 408-366-0848 10
