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Mastering IEC 62304 for Medical Device Software Development Life Cycle

Mastering IEC 62304 for Medical Device Software Development Life Cycle

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Mastering IEC 62304 for Medical Device Software Development Life Cycle

Gain comprehensive knowledge and skills to develop medical device software that meets the rigorous standards of IEC 62304. This course is designed to provide a detailed understanding of the software development life cycle, ensuring compliance with regulatory requirements.



Course Overview

This extensive and detailed course curriculum is organized into several chapters, covering at least 80 topics. Participants will receive a certificate upon completion, issued by The Art of Service.



Course Outline

Chapter 1: Introduction to IEC 62304

  • Overview of IEC 62304 standard
  • Importance of IEC 62304 in medical device software development
  • Key principles and objectives of IEC 62304
  • Relationship between IEC 62304 and other regulatory standards

Chapter 2: Software Development Life Cycle (SDLC)

  • Introduction to SDLC
  • Phases of SDLC: planning, requirements analysis, design, implementation, testing, and maintenance
  • SDLC models: waterfall, V-model, agile, and iterative
  • SDLC documentation and records

Chapter 3: Software Safety Classification

  • Understanding software safety classification
  • Classification based on risk: Class A, B, and C
  • Determining software safety classification
  • Impact of software safety classification on SDLC

Chapter 4: Software Requirements Analysis

  • Introduction to software requirements analysis
  • Types of software requirements: functional, performance, and safety
  • Techniques for gathering and documenting software requirements
  • Validation and verification of software requirements

Chapter 5: Software Design and Implementation

  • Software design principles and techniques
  • Software design documentation
  • Implementation: coding standards, code reviews, and unit testing
  • Integration and integration testing

Chapter 6: Software Testing and Validation

  • Software testing strategies and techniques
  • Types of software testing: unit, integration, system, and acceptance
  • Test documentation and records
  • Validation and verification of software testing

Chapter 7: Software Maintenance and Support

  • Software maintenance activities: corrective, preventive, and perfective
  • Software maintenance documentation and records
  • Support: customer support, technical support, and training
  • Change management and configuration management

Chapter 8: Risk Management

  • Introduction to risk management
  • Risk assessment and analysis
  • Risk mitigation and control
  • Risk management documentation and records

Chapter 9: Quality Management System (QMS)

  • Introduction to QMS
  • QMS requirements for medical device software development
  • QMS documentation and records
  • Auditing and compliance

Chapter 10: Regulatory Compliance

  • Overview of regulatory requirements for medical device software
  • Compliance with IEC 62304 and other regulatory standards
  • Regulatory submissions and approvals
  • Post-market surveillance and vigilance


Course Features

  • Interactive: engaging video lessons, quizzes, and assessments
  • Comprehensive: in-depth coverage of IEC 62304 and SDLC
  • Personalized: tailored learning experience with flexible pacing
  • Up-to-date: latest information on regulatory requirements and industry best practices
  • Practical: real-world examples and case studies
  • High-quality content: expert instructors and reviewed content
  • Certification: certificate upon completion issued by The Art of Service
  • Flexible learning: access course materials anywhere, anytime
  • User-friendly: intuitive course platform and mobile accessibility
  • Community-driven: discussion forums and support
  • Actionable insights: practical knowledge and skills
  • Hands-on projects: apply learning to real-world scenarios
  • Bite-sized lessons: manageable chunks of learning
  • Lifetime access: access course materials for life
  • Gamification: engaging learning experience with rewards and recognition
  • Progress tracking: monitor progress and achievement


What to Expect

Upon completing this course, participants will have gained a comprehensive understanding of IEC 62304 and the software development life cycle for medical device software. They will be able to apply this knowledge to develop compliant software, ensuring the highest level of safety and quality.

Receive a certificate upon completion, issued by The Art of Service

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