What does the ISO 14385 course cover?
ISO 14385 is covered here in 12 modules: Introduction to ISO 13485: History and evolution of the standard, Quality Management System (QMS) Fundamentals: Key components of a QMS, Risk Management: principles and concepts, Risk control and mitigation and 9 more.
How do you approach ISO 14385 step by step?
The work is sequenced in 12 stages. It starts with Introduction to ISO 13485: History and evolution of the standard, moves through Quality Management System (QMS) Fundamentals: Key components of a QMS and risk Management: principles and concepts, Risk control and mitigation, and ends at Certification and Maintenance: Maintenance principles and concepts.
What is in Module 1 of the ISO 14385 course?
Module 1 is Introduction to ISO 13485: History and evolution of the standard. It works through overview of ISO 13485 and its application in the medical device industry, history and evolution of the standard, key concepts and principles of ISO 13485 and 1 more. It sets the vocabulary the remaining 11 modules build on.
How is the ISO 14385 course delivered?
The ISO 14385 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 ISO 14385 course cost?
The ISO 14385 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: Medical Device Software Quality Management Toolkit, AI-Driven Quality Management for Medical Devices, AI-Driven Quality Management for Medical Device Software, Embedding Quality Culture in Medical Device Compliance.
More answers: what you get with every course, refund policy, all help answers.
Mastering ISO 13485: A Step-by-Step Guide to Implementing a Quality Management System for Medical Devices
Course Overview
This comprehensive course provides a step-by-step guide to implementing a quality management system (QMS) for medical devices based on the ISO 13485 standard. Participants will learn how to establish, implement, maintain, and continually improve a QMS that meets the requirements of ISO 13485.Course Objectives
- Understand the requirements of ISO 13485 and its application in the medical device industry
- Learn how to establish, implement, maintain, and continually improve a QMS for medical devices
- Understand the importance of risk management, quality control, and regulatory compliance in the medical device industry
- Develop the skills and knowledge needed to implement a QMS that meets the requirements of ISO 13485
- Prepare for certification audits and maintain a certified QMS
Course Outline
Module 1. Introduction to ISO 13485: History and evolution of the standard
- Overview of ISO 13485 and its application in the medical device industry
- History and evolution of the standard
- Key concepts and principles of ISO 13485
- Benefits of implementing a QMS based on ISO 13485
Module 2. Quality Management System (QMS) Fundamentals: Key components of a QMS
- Definition and scope of a QMS
- Key components of a QMS
- Quality policy and objectives
- Quality manual and procedures
Module 3. Risk Management: principles and concepts, Risk control and mitigation
- Introduction to risk management in the medical device industry
- Risk management principles and concepts
- Risk assessment and analysis
- Risk control and mitigation
Module 4. Quality Control: Inspection and testing, principles and concepts
- Introduction to quality control in the medical device industry
- Quality control principles and concepts
- Inspection and testing
- Statistical process control
Module 5. Regulatory Compliance: principles and concepts, CE marking and FDA clearance
- Overview of regulatory requirements for medical devices
- Regulatory compliance principles and concepts
- CE marking and FDA clearance
- Compliance with ISO 13485 and other standards
Module 6. Document Control and Records Management: Electronic document management systems
- Introduction to document control and records management
- Document control principles and concepts
- Records management principles and concepts
- Electronic document management systems
Module 7. Management Responsibility: Quality policy and objectives, Management review and evaluation
- Introduction to management responsibility in the medical device industry
- Management commitment and leadership
- Quality policy and objectives
- Management review and evaluation
Module 8. Resource Management: Work environment and safety, Human resources and training
- Introduction to resource management in the medical device industry
- Human resources and training
- Infrastructure and equipment
- Work environment and safety
Module 9. Product Realization: Product planning and design, Product release and delivery
- Introduction to product realization in the medical device industry
- Product planning and design
- Product development and testing
- Product release and delivery
Module 10. Measurement, Analysis, and Improvement: Data analysis and interpretation
- Introduction to measurement, analysis, and improvement in the medical device industry
- Performance measurement and monitoring
- Data analysis and interpretation
- Continual improvement and corrective action
Module 11. Internal Audits and Management Review: Audit and review techniques and tools
- Introduction to internal audits and management review in the medical device industry
- Internal audit principles and concepts
- Management review principles and concepts
- Audit and review techniques and tools
Module 12. Certification and Maintenance: Maintenance principles and concepts
- Introduction to certification and maintenance in the medical device industry
- Certification principles and concepts
- Maintenance principles and concepts
- Surveillance audits and recertification
Course Features
- Interactive and engaging: The course includes interactive lessons, quizzes, and games to keep you engaged and motivated.
- Comprehensive and personalized: The course covers all aspects of ISO 13485 and provides personalized feedback and guidance.
- Up-to-date and practical: The course is updated regularly to reflect the latest developments in the medical device industry and provides practical examples and case studies.
- Real-world applications: The course provides real-world examples and case studies to illustrate the application of ISO 13485 in the medical device industry.
- High-quality content: The course content is developed by experts in the field and is of high quality and relevance.
- Expert instructors: The course instructors are experienced professionals with expertise in ISO 13485 and the medical device industry.
- Certification: Participants receive a certificate upon completion of the course, issued by The Art of Service.
- Flexible learning: The course is available online and can be accessed at any time, allowing for flexible learning.
- User-friendly: The course is designed to be user-friendly and easy to navigate, with clear instructions and minimal technical requirements.
- Mobile-accessible: The course can be accessed on mobile devices, allowing for learning on-the-go.
- Community-driven: The course includes a community forum where participants can connect with each other and with instructors.
- Actionable insights: The course provides actionable insights and practical advice that can be applied in the workplace.
- Hands-on projects: The course includes hands-on projects and exercises to help participants apply their knowledge and skills.
- Bite-sized lessons: The course is divided into bite-sized lessons, making it easy to learn and retain information.
- Lifetime access: Participants have lifetime access to the course materials and can review them at any time.
- Gamification: The course includes gamification elements, such as points and badges, to make learning fun and engaging.
- Progress tracking: The course includes progress tracking features, allowing participants to track their progress and stay motivated.