Mastering IEC 60601 Standard Requirements for Medical Device Development
This comprehensive course is designed to provide participants with a thorough understanding of the IEC 60601 standard requirements for medical device development. Upon completion of this course, participants will receive a certificate issued by The Art of Service.Course Features - Interactive and engaging learning experience
- Comprehensive and personalized course content
- Up-to-date and practical information on IEC 60601 standard requirements
- Real-world applications and case studies
- High-quality content developed by expert instructors
- Certificate issued by The Art of Service upon completion
- Flexible learning options, including mobile accessibility
- User-friendly and community-driven learning platform
- Actionable insights and hands-on projects
- Bite-sized lessons and lifetime access to course materials
- Gamification and progress tracking features
Course Outline Chapter 1: Introduction to IEC 60601 Standard
Topic 1.1: Overview of IEC 60601 Standard
- Definition and scope of IEC 60601 standard
- History and evolution of IEC 60601 standard
- Importance of IEC 60601 standard in medical device development
Topic 1.2: Key Principles of IEC 60601 Standard
- Safety and effectiveness principles
- Risk management principles
- Usability and accessibility principles
Chapter 2: IEC 60601 Standard Requirements for Medical Device Development
Topic 2.1: General Requirements for Medical Devices
- Labeling and instructions for use
- Packaging and transportation
- Storage and maintenance
Topic 2.2: Electrical Safety Requirements
- Electrical shock protection
- Electromagnetic compatibility
- Electrical isolation and insulation
Topic 2.3: Mechanical Safety Requirements
- Mechanical strength and durability
- Mechanical hazards and risks
- Biocompatibility and toxicity
Chapter 3: Risk Management and Usability Engineering
Topic 3.1: Risk Management Principles and Process
- Risk identification and analysis
- Risk evaluation and control
- Risk monitoring and review
Topic 3.2: Usability Engineering Principles and Process
- User needs and requirements
- User interface design and testing
- Usability validation and verification
Chapter 4: Software Development and Validation
Topic 4.1: Software Development Life Cycle
- Software planning and requirements
- Software design and implementation
- Software testing and validation
Topic 4.2: Software Validation and Verification
- Software validation principles and process
- Software verification principles and process
- Software validation and verification techniques
Chapter 5: Clinical Evaluation and Clinical Trials
Topic 5.1: Clinical Evaluation Principles and Process
- Clinical evaluation planning and design
- Clinical evaluation conduct and monitoring
- Clinical evaluation analysis and reporting
Topic 5.2: Clinical Trials Principles and Process
- Clinical trial planning and design
- Clinical trial conduct and monitoring
- Clinical trial analysis and reporting
Chapter 6: Regulatory Compliance and Approval
Topic 6.1: Regulatory Compliance Principles and Process
- Regulatory requirements and standards
- Regulatory submission and approval process
- Regulatory compliance and maintenance
Topic 6.2: FDA and EU Regulatory Requirements
- FDA regulatory requirements and process
- EU regulatory requirements and process
- Comparison of FDA and EU regulatory requirements
Chapter 7: Post-Market Surveillance and Vigilance
Topic 7.1: Post-Market Surveillance Principles and Process
- Post-market surveillance planning and design
- Post-market surveillance conduct and monitoring
- Post-market surveillance analysis and reporting
Topic 7.2: Vigilance and Adverse Event Reporting
- Vigilance principles and process
- Adverse event reporting principles and process
- Vigilance and adverse event reporting requirements
Chapter 8: Quality Management and Auditing
Topic 8.1: Quality Management Principles and Process
- Quality management planning and design
- Quality management conduct and monitoring
- Quality management analysis and reporting
Topic 8.2: Auditing Principles and Process
- Auditing planning and design
- Auditing conduct and monitoring
- Auditing analysis and reporting
Chapter 9: Medical Device Software and Cybersecurity
Topic 9.1: Medical Device Software Principles and Process
- Medical device software planning and design
- Medical device software conduct and monitoring
- Medical device software analysis and reporting
Chapter 1: Introduction to IEC 60601 Standard
Topic 1.1: Overview of IEC 60601 Standard
- Definition and scope of IEC 60601 standard
- History and evolution of IEC 60601 standard
- Importance of IEC 60601 standard in medical device development
Topic 1.2: Key Principles of IEC 60601 Standard
- Safety and effectiveness principles
- Risk management principles
- Usability and accessibility principles
Chapter 2: IEC 60601 Standard Requirements for Medical Device Development
Topic 2.1: General Requirements for Medical Devices
- Labeling and instructions for use
- Packaging and transportation
- Storage and maintenance
Topic 2.2: Electrical Safety Requirements
- Electrical shock protection
- Electromagnetic compatibility
- Electrical isolation and insulation
Topic 2.3: Mechanical Safety Requirements
- Mechanical strength and durability
- Mechanical hazards and risks
- Biocompatibility and toxicity
Chapter 3: Risk Management and Usability Engineering
Topic 3.1: Risk Management Principles and Process
- Risk identification and analysis
- Risk evaluation and control
- Risk monitoring and review
Topic 3.2: Usability Engineering Principles and Process
- User needs and requirements
- User interface design and testing
- Usability validation and verification
Chapter 4: Software Development and Validation
Topic 4.1: Software Development Life Cycle
- Software planning and requirements
- Software design and implementation
- Software testing and validation
Topic 4.2: Software Validation and Verification
- Software validation principles and process
- Software verification principles and process
- Software validation and verification techniques
Chapter 5: Clinical Evaluation and Clinical Trials
Topic 5.1: Clinical Evaluation Principles and Process
- Clinical evaluation planning and design
- Clinical evaluation conduct and monitoring
- Clinical evaluation analysis and reporting
Topic 5.2: Clinical Trials Principles and Process
- Clinical trial planning and design
- Clinical trial conduct and monitoring
- Clinical trial analysis and reporting
Chapter 6: Regulatory Compliance and Approval
Topic 6.1: Regulatory Compliance Principles and Process
- Regulatory requirements and standards
- Regulatory submission and approval process
- Regulatory compliance and maintenance
Topic 6.2: FDA and EU Regulatory Requirements
- FDA regulatory requirements and process
- EU regulatory requirements and process
- Comparison of FDA and EU regulatory requirements
Chapter 7: Post-Market Surveillance and Vigilance
Topic 7.1: Post-Market Surveillance Principles and Process
- Post-market surveillance planning and design
- Post-market surveillance conduct and monitoring
- Post-market surveillance analysis and reporting
Topic 7.2: Vigilance and Adverse Event Reporting
- Vigilance principles and process
- Adverse event reporting principles and process
- Vigilance and adverse event reporting requirements
Chapter 8: Quality Management and Auditing
Topic 8.1: Quality Management Principles and Process
- Quality management planning and design
- Quality management conduct and monitoring
- Quality management analysis and reporting
Topic 8.2: Auditing Principles and Process
- Auditing planning and design
- Auditing conduct and monitoring
- Auditing analysis and reporting
Chapter 9: Medical Device Software and Cybersecurity
Topic 9.1: Medical Device Software Principles and Process
- Medical device software planning and design
- Medical device software conduct and monitoring
- Medical device software analysis and reporting