What does the IEC 62304 course cover?
IEC 62304 is covered here in 8 modules: Introduction to IEC 62304: Key concepts and terminology, History and evolution of the standard, Software Development Life Cycle: Testing and validation, Maintenance and updates, Risk Management: principles and concepts, Risk monitoring and review and 5 more.
How do you approach IEC 62304 step by step?
The work is sequenced in 8 stages. It starts with introduction to IEC 62304: Key concepts and terminology, History and evolution of the standard, moves through Software Development Life Cycle: Testing and validation, Maintenance and updates and risk Management: principles and concepts, Risk monitoring and review, and ends at implementation and Maintenance: principles and concepts, Continuous improvement and updates.
What is in Module 1 of the IEC 62304 course?
Module 1 is Introduction to IEC 62304: Key concepts and terminology, History and evolution of the standard. It works through overview of IEC 62304 and its importance in medical device software development, key concepts and terminology and history and evolution of the standard. It sets the vocabulary the remaining 7 modules build on.
How is the IEC 62304 course delivered?
The IEC 62304 course is fully self-paced with immediate online access after enrolment. Access does not expire and future updates are included at no cost. It can be taken on any device, and a certificate of completion is issued by The Art of Service when you finish.
How much does the IEC 62304 course cost?
The IEC 62304 course is $199 as a one time payment. There is no subscription, no per seat licence and no hidden fee. Enrolment carries a 30 day satisfied or refunded guarantee, so it can be assessed in full before you commit.
Closely related courses: IEC 62304 for Medical Device Software Compliance, IEC 60601 Standard Requirements for Medical Device, IEC 60601 Standard Requirements for Medical Device Design, IEC 62304 Compliance for Medical Device Software.
More answers: what you get with every course, refund policy, all help answers.
Mastering IEC 62304: A Step-by-Step Guide to Medical Device Software Development and Risk Management
Course Overview
This comprehensive course provides a step-by-step guide to mastering IEC 62304, the international standard for medical device software development and risk management. Participants will receive a certificate upon completion, issued by The Art of Service.Course Features
- Interactive: Engage with expert instructors and peers through interactive discussions and hands-on projects.
- Engaging: Enjoy a user-friendly and mobile-accessible learning platform with bite-sized lessons and gamification.
- Comprehensive: Cover all aspects of IEC 62304, from software development to risk management.
- Personalized: Receive personalized feedback and support from expert instructors.
- Up-to-date: Stay current with the latest developments and updates in the field.
- Practical: Apply theoretical knowledge to real-world applications and case studies.
- High-quality content: Access high-quality course materials, including video lectures, readings, and quizzes.
- Certification: Receive a certificate upon completion, issued by The Art of Service.
- Flexible learning: Learn at your own pace, with lifetime access to course materials.
- Community-driven: Join a community of professionals and stay connected with peers and instructors.
- Actionable insights: Gain actionable insights and practical skills to apply in your career.
Course Outline
Module 1. Introduction to IEC 62304: Key concepts and terminology, History and evolution of the standard
- Overview of IEC 62304 and its importance in medical device software development
- Key concepts and terminology
- History and evolution of the standard
Module 2. Software Development Life Cycle: Testing and validation, Maintenance and updates
- Software development life cycle models
- Requirements gathering and analysis
- Design and implementation
- Testing and validation
- Maintenance and updates
Module 3. Risk Management: principles and concepts, Risk monitoring and review
- Risk management principles and concepts
- Risk analysis and assessment
- Risk mitigation and control
- Risk monitoring and review
Module 4. Software Safety and Security: principles and concepts, Safety and security requirements
- Software safety and security principles and concepts
- Hazard analysis and risk assessment
- Safety and security requirements
- Design and implementation of safety and security features
Module 5. Verification and Validation: principles and concepts, Test planning and execution
- Verification and validation principles and concepts
- Testing strategies and techniques
- Test planning and execution
- Test results analysis and reporting
Module 6. Documentation and Record-Keeping: principles and concepts, Risk management documentation
- Documentation and record-keeping principles and concepts
- Software development documentation
- Risk management documentation
- Verification and validation documentation
Module 7. Audits and Inspections: Audit planning and execution, Inspection planning and execution
- Audit and inspection principles and concepts
- Audit planning and execution
- Inspection planning and execution
- Audit and inspection reporting and follow-up
Module 8. Implementation and Maintenance: principles and concepts, Continuous improvement and updates
- Implementation and maintenance principles and concepts
- Software development and maintenance processes
- Risk management and maintenance processes
- Continuous improvement and updates