What does the ISO 13485 Certification Masterclass for Medical Device Quality course cover?
ISO 13485 Certification Masterclass for Medical Device Quality is covered here in 10 modules: Introduction to ISO 13485: History and evolution of ISO 13485, Quality Management System (QMS) Fundamentals: QMS principles and framework, ISO 13485 Requirements: Clause 6: Resource management, Clause 7: Product realization and 7 more.
How do you approach ISO 13485 Certification Masterclass for Medical Device Quality step by step?
The work is sequenced in 10 stages. It starts with Introduction to ISO 13485: History and evolution of ISO 13485, moves through Quality Management System (QMS) Fundamentals: QMS principles and framework and ISO 13485 Requirements: Clause 6: Resource management, Clause 7: Product realization, and ends at ISO 13485 Certification and Implementation: Certification audit and surveillance.
What is in Module 1 of the ISO 13485 Certification Masterclass for Medical Device Quality course?
Module 1 is Introduction to ISO 13485: History and evolution of ISO 13485. It works through history and evolution of ISO 13485, key principles and benefits of ISO 13485, relationship between ISO 13485 and other quality management standards and 1 more. It sets the vocabulary the remaining 9 modules build on.
Who is the ISO 13485 Certification Masterclass for Medical Device Quality course for?
It is written for people accountable for ISO 13485 Certification Masterclass for Medical Device Quality rather than for a general audience. The published outcomes are introduction to ISO 13485, Quality Management System (QMS) Fundamentals, ISO 13485 Requirements and 7 more. It assumes you apply the material to your own environment.
How is the ISO 13485 Certification Masterclass for Medical Device Quality course delivered?
The ISO 13485 Certification Masterclass for Medical Device Quality 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 13485 Certification Masterclass for Medical Device Quality course cost?
The ISO 13485 Certification Masterclass for Medical Device Quality 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: ISO 14155 Masterclass, Medical Device Classification and Medical Device, Medical Device Reporting and Medical Device Regulation, Medical Device Reporting Toolkit.
More answers: what you get with every course, refund policy, all help answers.
ISO 13485 Certification Masterclass for Medical Device Quality Management Systems
Join our comprehensive course and gain in-depth knowledge of ISO 13485 certification for medical device quality management systems. Upon completion, receive a certificate issued by The Art of Service.Course Overview
This interactive and engaging course is designed to provide a thorough understanding of ISO 13485 and its application in medical device quality management systems. The curriculum is organized into the following chapters:- Introduction to ISO 13485
- Quality Management System (QMS) Fundamentals
- ISO 13485 Requirements
- Medical Device Quality Management Systems
- Risk Management and ISO 14971
- Design and Development Controls
- Production and Service Controls
- Measurement, Analysis, and Improvement
- Internal Audits and Management Review
- ISO 13485 Certification and Implementation
Module 1. Introduction to ISO 13485: History and evolution of ISO 13485
This module provides an overview of the ISO 13485 standard and its significance in the medical device industry.- History and evolution of ISO 13485
- Key principles and benefits of ISO 13485
- Relationship between ISO 13485 and other quality management standards
- Regulatory requirements and ISO 13485
Module 2. Quality Management System (QMS) Fundamentals: QMS principles and framework
This module covers the fundamental concepts of a quality management system and its application in the medical device industry.- QMS definitions and terminology
- QMS principles and framework
- QMS documentation and record-keeping
- QMS implementation and maintenance
Module 3. ISO 13485 Requirements: Clause 6: Resource management, Clause 7: Product realization
This module provides an in-depth review of the ISO 13485 standard and its requirements.- Clause 4: Quality management system
- Clause 5: Management responsibility
- Clause 6: Resource management
- Clause 7: Product realization
- Clause 8: Measurement, analysis, and improvement
Module 4. Medical Device Quality Management Systems: Medical device regulations and standards
This module explores the application of ISO 13485 in medical device quality management systems.- Medical device regulations and standards
- Medical device quality management system requirements
- Design and development controls for medical devices
- Production and service controls for medical devices
Module 5. Risk Management and ISO 14971: Risk assessment and mitigation
This module covers the principles and application of risk management in medical device quality management systems.- Risk management definitions and terminology
- ISO 14971 and risk management requirements
- Risk assessment and mitigation
- Risk management documentation and record-keeping
Module 6. Design and Development Controls: Design and development planning
This module provides an in-depth review of design and development controls for medical devices.- Design and development planning
- Design and development inputs and outputs
- Design and development reviews and verification
- Design and development validation and transfer
Module 7. Production and Service Controls: Production planning and control
This module covers the principles and application of production and service controls for medical devices.- Production planning and control
- Production and service delivery
- Production and service monitoring and measurement
- Production and service nonconformity and corrective action
Module 8. Measurement, Analysis, and Improvement: Quality management system audit and review
This module explores the principles and application of measurement, analysis, and improvement in medical device quality management systems.- Monitoring and measurement of quality management system performance
- Analysis and evaluation of quality management system data
- Continual improvement and corrective action
- Quality management system audit and review
Module 9. Internal Audits and Management Review: Internal audit principles and planning
This module provides an overview of internal audits and management review in medical device quality management systems.- Internal audit principles and planning
- Internal audit execution and reporting
- Management review and quality management system evaluation
- Continual improvement and corrective action
Module 10. ISO 13485 Certification and Implementation: Certification audit and surveillance
This module covers the principles and application of ISO 13485 certification and implementation.- ISO 13485 certification process and requirements
- Implementation planning and project management
- Gap analysis and readiness assessment
- Certification audit and surveillance
Course Benefits
Upon completion of this course, participants will:- Gain a comprehensive understanding of ISO 13485 and its application in medical device quality management systems
- Understand the requirements and principles of a quality management system
- Learn how to implement and maintain a quality management system that meets ISO 13485 requirements
- Understand the importance of risk management and its application in medical device quality management systems
- Receive a certificate issued by The Art of Service upon completion