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Mastering Medical Device Software Quality Management; A Step-by-Step Guide

Mastering Medical Device Software Quality Management; A Step-by-Step Guide

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Mastering Medical Device Software Quality Management: A Step-by-Step Guide



Course Overview

This comprehensive course provides a step-by-step guide to mastering medical device software quality management. Participants will gain a deep understanding of the principles, regulations, and best practices for ensuring the quality and safety of medical device software. Upon completion, participants will receive a certificate issued by The Art of Service.



Course Features

  • Interactive and engaging learning experience
  • Comprehensive and up-to-date content
  • Personalized learning with expert instructors
  • Practical and real-world applications
  • High-quality content and certification
  • Flexible learning with lifetime access
  • User-friendly and mobile-accessible platform
  • Community-driven with actionable insights
  • Hands-on projects and bite-sized lessons
  • Gamification and progress tracking


Course Outline

Module 1: Introduction to Medical Device Software Quality Management

  • Definition and importance of medical device software quality management
  • Regulatory requirements and industry standards
  • Overview of the software development lifecycle
  • Quality management principles and best practices

Module 2: Software Development Lifecycle (SDLC)

  • Phases of the SDLC: planning, design, development, testing, and deployment
  • Software development methodologies: Agile, Waterfall, and Hybrid
  • Software quality metrics and measurement
  • Risk management and mitigation strategies

Module 3: Regulatory Requirements and Industry Standards

  • Overview of FDA regulations: 21 CFR Part 820 and 21 CFR Part 11
  • EU MDR and IVDR regulations
  • IEC 62304 and ISO 13485 standards
  • Compliance and auditing requirements

Module 4: Software Quality Assurance (SQA)

  • SQA principles and best practices
  • Software quality planning and control
  • Software testing and validation
  • Software configuration management and change control

Module 5: Software Quality Control (SQC)

  • SQC principles and best practices
  • Software quality metrics and measurement
  • Software testing and validation
  • Software defect management and tracking

Module 6: Software Validation and Verification

  • Software validation and verification principles and best practices
  • Software testing methodologies: black box, white box, and gray box
  • Software testing levels: unit, integration, system, and acceptance
  • Software validation and verification documentation

Module 7: Software Configuration Management (SCM)

  • SCM principles and best practices
  • Software configuration management planning and control
  • Software change management and tracking
  • Software configuration management tools and techniques

Module 8: Software Risk Management

  • Software risk management principles and best practices
  • Software risk assessment and mitigation strategies
  • Software risk management planning and control
  • Software risk management documentation

Module 9: Auditing and Compliance

  • Auditing principles and best practices
  • Compliance and auditing requirements
  • Audit planning and execution
  • Audit reporting and follow-up

Module 10: Continuous Improvement and Maintenance

  • Continuous improvement principles and best practices
  • Software maintenance and support
  • Software quality metrics and measurement
  • Software process improvement and optimization


Certificate

Upon completion of the course, participants will receive a certificate issued by The Art of Service, demonstrating their mastery of medical device software quality management principles and practices.

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