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Medical Device Software Quality Management Self-Assessment Checklist Training

Medical Device Software Quality Management Self-Assessment Checklist Training

$199.00
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Medical Device Software Quality Management Self-Assessment Checklist Training Curriculum

This comprehensive training program is designed to equip professionals with the knowledge and skills necessary to develop and implement a robust quality management system for medical device software. Upon completion, participants will receive a certificate issued by The Art of Service.



Course Overview

This interactive and engaging course is structured into 8 modules, covering over 80 topics related to medical device software quality management. The curriculum is designed to be comprehensive, practical, and relevant to real-world applications.



Course Outline

Module 1: Introduction to Medical Device Software Quality Management

  • Overview of medical device software regulations and standards
  • Importance of quality management in medical device software development
  • Introduction to the self-assessment checklist
  • Understanding the role of quality management in ensuring patient safety

Module 2: Quality Management System (QMS) Fundamentals

  • QMS principles and framework
  • ISO 13485:2016 and ISO 9001:2015 standards overview
  • QMS documentation and record-keeping requirements
  • Establishing a QMS for medical device software development

Module 3: Software Development Life Cycle (SDLC)

  • SDLC methodologies and models
  • Requirements gathering and analysis
  • Design, implementation, testing, and validation
  • Change management and configuration control

Module 4: Risk Management for Medical Device Software

  • Risk management principles and framework
  • Identifying and assessing risks in medical device software
  • Risk control measures and mitigation strategies
  • Risk management documentation and review

Module 5: Software Verification and Validation

  • Verification and validation principles and techniques
  • Testing strategies and methodologies
  • Test case development and execution
  • Defect tracking and resolution

Module 6: Quality Assurance and Quality Control

  • Quality assurance principles and activities
  • Quality control measures and techniques
  • Auditing and inspection techniques
  • Corrective action and preventive action (CAPA)

Module 7: Regulatory Compliance and Submission

  • Regulatory requirements for medical device software
  • Preparing for regulatory submissions
  • Documentation and record-keeping requirements
  • Working with regulatory agencies

Module 8: Self-Assessment and Continuous Improvement

  • Using the self-assessment checklist for QMS evaluation
  • Identifying areas for improvement
  • Developing a plan for continuous improvement
  • Maintaining and updating the QMS


Course Features

This course is designed to be:

  • Interactive: Engaging exercises and quizzes to reinforce learning
  • Comprehensive: Covering over 80 topics related to medical device software quality management
  • Personalized: Opportunities for feedback and questions
  • Up-to-date: Incorporating the latest regulations and industry best practices
  • Practical: Real-world examples and case studies
  • High-quality content: Developed by expert instructors with industry experience
  • Flexible learning: Self-paced online learning with lifetime access
  • User-friendly: Easy-to-use online platform with mobile accessibility
  • Community-driven: Discussion forums for peer-to-peer learning and networking
  • Actionable insights: Practical takeaways and recommendations for implementation
  • Hands-on projects: Opportunities to apply learning to real-world scenarios
  • Bite-sized lessons: Short, focused lessons for easy learning
  • Gamification: Engaging elements to enhance the learning experience
  • Progress tracking: Tools to track progress and stay motivated
Upon completion, participants will receive a certificate issued by The Art of Service, demonstrating their expertise in medical device software quality management.

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