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IEC 62304 Standard for Medical Device Software Development Life Cycle Training

IEC 62304 Standard for Medical Device Software Development Life Cycle Training

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IEC 62304 Standard for Medical Device Software Development Life Cycle Training



Course Overview

This comprehensive course is designed to provide an in-depth understanding of the IEC 62304 standard for medical device software development life cycle. Participants will learn how to apply the standard to their software development processes, ensuring compliance with regulatory requirements.



Course Objectives

  • Understand the IEC 62304 standard and its application to medical device software development
  • Learn how to implement the standard in software development life cycle processes
  • Understand the importance of risk management in medical device software development
  • Gain knowledge on how to conduct audits and assessments to ensure compliance with the standard


Course Outline

Module 1: Introduction to IEC 62304 Standard

  • Overview of the IEC 62304 standard
  • History and evolution of the standard
  • Key principles and concepts
  • Scope and applicability of the standard

Module 2: Software Development Life Cycle

  • Overview of software development life cycle (SDLC)
  • SDLC models (e.g., waterfall, agile, hybrid)
  • SDLC phases (e.g., requirements, design, implementation, testing)
  • Importance of SDLC in medical device software development

Module 3: Risk Management

  • Introduction to risk management
  • Risk assessment and analysis
  • Risk mitigation and control
  • Risk management in medical device software development

Module 4: Software Requirements

  • Software requirements definition
  • Software requirements analysis
  • Software requirements documentation
  • Software requirements validation

Module 5: Software Design

  • Software design principles
  • Software design documentation
  • Software design verification
  • Software design validation

Module 6: Software Implementation

  • Software implementation principles
  • Software coding standards
  • Software code review
  • Software testing

Module 7: Software Testing and Validation

  • Software testing principles
  • Software testing types (e.g., unit testing, integration testing)
  • Software testing documentation
  • Software validation

Module 8: Software Maintenance and Support

  • Software maintenance principles
  • Software maintenance documentation
  • Software support
  • Software change management

Module 9: Configuration Management

  • Configuration management principles
  • Configuration identification
  • Configuration control
  • Configuration status accounting

Module 10: Quality Management

  • Quality management principles
  • Quality management system (QMS)
  • QMS documentation
  • QMS auditing and assessment

Module 11: Auditing and Assessment

  • Auditing principles
  • Audit types (e.g., internal, external)
  • Audit planning and preparation
  • Audit execution and reporting

Module 12: Regulatory Compliance

  • Regulatory requirements for medical device software
  • Compliance with IEC 62304 standard
  • Compliance with other regulatory requirements (e.g., FDA, EU MDR)
  • Regulatory auditing and assessment


Course Features

  • Interactive: Engaging video lessons, quizzes, and assessments
  • Comprehensive: In-depth coverage of the IEC 62304 standard and its application
  • Personalized: Learn at your own pace and track your progress
  • Up-to-date: Latest information and updates on the IEC 62304 standard
  • Practical: Real-world examples and case studies
  • High-quality content: Expert instructors and high-quality video lessons
  • Certification: Receive a certificate upon completion issued by The Art of Service
  • Flexible learning: Learn anytime, anywhere on any device
  • User-friendly: Easy-to-use platform and navigation
  • Mobile-accessible: Learn on-the-go on your mobile device
  • Community-driven: Discussion forums and community support
  • Actionable insights: Practical knowledge and skills to apply to your work
  • Hands-on projects: Apply your knowledge and skills to real-world projects
  • Bite-sized lessons: Short and focused lessons for easy learning
  • Lifetime access: Access the course materials for a lifetime
  • Gamification: Engaging gamification elements to enhance learning
  • Progress tracking: Track your progress and stay motivated


Certificate of Completion

Upon completing the course, participants will receive a Certificate of Completion issued by The Art of Service. This certificate is a recognition of your expertise and knowledge in IEC 62304 standard for medical device software development life cycle.

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