About Course
Course Duration: 2 Days – 8 Hours/day
This two-day course is designed to give the attendee a detailed understanding of developing and maintaining Medical Device Software following the requirements of IEC 62304. The course covers the relationship of IEC 62304 with related standards such as ISO 13485, ISO 14971 and IEC 60601.
Course Outline
Day One
- Chapter 1: Introduction and Overview
- Definition
- History
- Structure
- Key Concepts
- General Requirements and Software Safety Classification
- Chapter 2: Initiation of Software Development
- Software Development Planning and New Product Development
- Deriving Software Requirements from System Requirements through Software Requirements Analysis
- Breakout Exercise: Writing Effective Software Requirements for Medical devices
- Chapter 3: Software Design
- Software Architectural Design
- Software Detailed Design
- Breakout Exercise: Architectural Design
Day Two
- Chapter 4: Software Verification and Testing
- Unit Implementation and Verification
- Integration and Integration Testing
- Software System Testing and Release
- Relationship to IEC 60601 – General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment
- Breakout Exercise: Testing for Medical Device Software using Test plans
- Chapter 5: Software Maintenance Process
- Maintenance Planning, Problem Analysis and Modification Implementation
- Chapter 6: Supporting Processes
- Software Risk Management (and relationship to ISO 14971)
- Changes and Configuration Management
- Issue Resolution Process
- Breakout Exercise: Performing Software Risk Management
- Chapter 7: Integrating IEC 62304 into Medical Device Companies
- Integrating with ISO 13485 – Medical Devices Quality Management System
- Breakout Exercise: Integration of IEC 62304 into your Organization’s Quality Management System
