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Mastering IEC 62304 Second Edition; Practical Tools for Medical Device Software Self-Assessment

Mastering IEC 62304 Second Edition; Practical Tools for Medical Device Software Self-Assessment

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Mastering IEC 62304 Second Edition: Practical Tools for Medical Device Software Self-Assessment



Course Overview

This comprehensive course is designed to provide participants with a thorough understanding of the IEC 62304 standard for medical device software development and maintenance. Through interactive lessons, hands-on projects, and real-world applications, participants will gain the knowledge and skills necessary to conduct self-assessments and ensure compliance with regulatory requirements.



Course Objectives

  • Understand the requirements of IEC 62304 Second Edition for medical device software development and maintenance
  • Learn practical tools and techniques for conducting self-assessments and ensuring compliance
  • Apply knowledge and skills to real-world scenarios and case studies
  • Develop a comprehensive understanding of the standard's requirements for software development, testing, and maintenance
  • Improve ability to identify and mitigate risks associated with medical device software


Course Outline

Module 1: Introduction to IEC 62304 Second Edition

  • Overview of the standard's history and evolution
  • Key changes and updates in the Second Edition
  • Scope and applicability of the standard
  • Relationship to other regulatory requirements and standards

Module 2: Software Development and Maintenance Requirements

  • Software development process requirements
  • Software maintenance process requirements
  • Requirements for software risk management
  • Requirements for software testing and validation

Module 3: Software Life Cycle Processes

  • Software development life cycle processes
  • Software maintenance life cycle processes
  • Requirements for software documentation and records
  • Requirements for software configuration management

Module 4: Software Risk Management

  • Principles of software risk management
  • Software risk management process requirements
  • Techniques for identifying and mitigating software risks
  • Requirements for software risk management documentation

Module 5: Software Testing and Validation

  • Principles of software testing and validation
  • Software testing and validation process requirements
  • Techniques for software testing and validation
  • Requirements for software testing and validation documentation

Module 6: Auditing and Compliance

  • Principles of auditing and compliance
  • Auditing process requirements
  • Techniques for conducting audits
  • Requirements for audit documentation and follow-up

Module 7: Case Studies and Group Discussions

  • Real-world case studies of IEC 62304 implementation
  • Group discussions and sharing of best practices
  • Hands-on exercises and activities


Course Features

  • Interactive lessons with hands-on exercises and activities
  • Comprehensive course materials with detailed explanations and examples
  • Expert instructors with extensive experience in medical device software development and regulatory compliance
  • Certificate of Completion issued by The Art of Service upon completion of the course
  • Lifetime access to course materials and online community
  • Flexible learning with self-paced online access
  • Mobile-accessible course materials and online community
  • Community-driven online forum for discussion and sharing of best practices
  • Actionable insights and practical tools for implementation
  • Hands-on projects and real-world applications
  • Bite-sized lessons for easy learning and retention
  • Progress tracking and feedback mechanisms
  • Gamification elements to enhance engagement and motivation


Course Benefits

  • Gain a comprehensive understanding of IEC 62304 Second Edition requirements
  • Develop practical skills and tools for conducting self-assessments and ensuring compliance
  • Improve ability to identify and mitigate risks associated with medical device software
  • Enhance knowledge and skills in software development, testing, and maintenance
  • Stay up-to-date with regulatory requirements and industry best practices
  • Network with peers and experts in the field through online community and discussion forums
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