Learning Plan:

• Software Development Life Cycle (SDLC) for Medical Devices:
  • Study IEC 62304 in depth, focusing on software safety classification and its implications
  • Learn about adapting Agile methodologies for medical device software (AAMI TIR45)
• Software Verification and Validation Specifics:
  • Focus on software-specific V&V techniques (e.g., static code analysis, unit testing, integration testing)
  • Learn about test automation and continuous integration for software
• Cybersecurity for Connected Medical Devices:
  • Study UL 2900 series for cybersecurity of network-connectable products
  • Learn about NIST Cybersecurity Framework and how it applies to medical devices
• Software Architecture and Design Patterns:
  • Understand common architectural patterns for medical device software
  • Learn about design patterns that promote safety and reliability
• Cloud Computing in Medical Devices:
  • Study FDA guidance on use of cloud computing in medical devices
  • Learn about HIPAA compliance for cloud-based healthcare applications

Implementation Plan:

• Gap Analysis for Software Processes:
  • Assess current QMS against IEC 62304 requirements
  • Identify areas where existing processes need to be adapted for software
• Integrate Software Development into QMS:
  • Update QMS to include software-specific processes and procedures
  • Ensure traceability between software requirements, design, and testing
• Establish Software-Specific SDLC:
  • Define software development methodology (e.g., Agile-Waterfall hybrid)
  • Create templates for software documentation (e.g., Software Requirements Specification, Software Design Document)
• Implement Software Configuration Management:
  • Set up version control system (if not already in place)
  • Establish branching and merging strategies for software development
• Enhance Verification and Validation for Software:
  • Implement code review processes
  • Set up automated testing infrastructure
  • Define software-specific validation protocols
• Develop Cybersecurity Processes:
  • Create a Secure Development Lifecycle (SDL) process
  • Establish vulnerability management and incident response procedures
  • Implement secure coding guidelines
• Establish Cloud-Specific Processes:
  • Develop procedures for cloud service provider selection and management
  • Establish data management and privacy protection processes for cloud-based systems
• Adapt Risk Management for Software:
  • Update risk management procedures to include software-specific hazards and mitigations
  • Implement software FMEA (Failure Mode and Effects Analysis) process
• Enhance Change Control for Software:
  • Adapt change control process to handle frequent software updates
  • Implement a process for managing third-party software and libraries