Context for Validation, Verification, and Risk Analysis within the Medical Device Project

• Where do Validation, Verification, and Risk Analysis come from?
• FDA vs. ISO perspective
• FDA regulations (law)
• Related FDA guidelines
• Context from ISO 13485 standard
• Context from ISO 14971 standard
• Related aspects of FDA regulations/ISO standard
  • Planning
  • Design Input, Output
  • Reviews
  • Record keeping
  • Documentation standards 

Context within Procedure Based Quality System

• Purpose of quality system
• Need for Validation, Verification, and Risk Analysis Procedures
• Typical content for
  • Validation and Verification procedure
  • Risk Analysis Procedure

Development of Validation and Verification Plan

• Purpose of the Validation and Verification Plan
• Typical Contents of Validation and Verification Plan
• Some typical medical device technologies
• V&V planning methodologies needed for various medical device technologies 

Use of Validation and Verification Protocols

• Purpose of the Validation and Verification protocol template
• Sections of V&V protocol template
• Traceability considerations
• Style for test input, expected results, actual result, signatures
• How to determine expected results

Validation Methodologies

• What is the definition of Validation
• What are the different types of Validation
• What is difference between Design Validation and Process Validation?
• Using Process Validation model for SW development tools

• Start with requirement specifications as basis of what to apply V&V towards
• Determining test classes and test types
• Developing a matrix to provide overview – bring it back to V&V plan
• Special Cases
  • Reliability assessment
  • Designed experiments
  • HALT/HASS

Methodologies to Analyze Risk

• Various tools and method that are used for purpose of risk determination
• Common design risk evaluation tools/methods
  • FMEA/FMECAs (Failure Modes and Effects Analysis/ Failure Modes and Effects and Criticality Analysis
  • FTA (Fault Tree Analysis)
  • Summary Risk Analysis
• Other risk evaluation methods
  • Process FMEAs
  • PHA (Preliminary Hazard Analysis)
  • HACCP (Hazard Analysis and Critical Control Points)
  • HAZOP (Hazard and Operability Analysis)

Creation of Summary Risk Analysis

• Defining Hazards
• Typical Hazards for various types of medical devices
• Using a Risk Analysis template from Global Harmonization Task Force
• Severity Determination
• Probability Determination
• Risk Determination
• Risk Mitigation
• Residual Risk

• FDA Guidance
• ISO standards
• ISO guidance
• GHTF

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