Mastering ISO 13485: A Step-by-Step Guide to Medical Device Quality Management System Implementation and Auditing

This comprehensive course is designed to provide participants with a thorough understanding of the ISO 13485 standard and its application in implementing and auditing a quality management system for medical devices.

Upon completion of this course, participants will receive a certificate issued by The Art of Service.

• Topic 1.1: Overview of ISO 13485 Introduction to the ISO 13485 standard, its purpose, and scope.

• Topic 1.2: History and Evolution of ISO 13485 Understanding the development and changes to the ISO 13485 standard over time.

• Topic 1.3: Key Principles and Concepts Exploring the fundamental principles and concepts of ISO 13485, including risk management and quality management.

• Topic 2.1: Establishing a QMS Framework Defining the structure and responsibilities for implementing a QMS.

• Topic 2.2: Quality Policy and Objectives Developing a quality policy and setting quality objectives.

• Topic 2.3: Quality Manual and Procedures Creating a quality manual and procedures for the QMS.

• Topic 2.4: Document Control and Record Keeping Implementing document control and record-keeping procedures.

• Topic 2.5: Training and Awareness Providing training and awareness programs for employees.

• Topic 3.1: Risk Management Principles and Techniques Understanding risk management principles and techniques.

• Topic 3.2: Identifying and Assessing Risks Identifying and assessing risks associated with medical devices.

• Topic 3.3: Risk Mitigation and Control Implementing risk mitigation and control measures.

• Topic 3.4: Quality Planning and Objectives Developing quality plans and objectives.

• Topic 4.1: Design and Development Planning Planning and controlling design and development activities.

• Topic 4.2: Design Input and Output Defining design input and output requirements.

• Topic 4.3: Design Review and Verification Conducting design reviews and verification activities.

• Topic 4.4: Design Validation and Transfer Performing design validation and transfer activities.

• Topic 5.1: Production Planning and Control Planning and controlling production activities.

• Topic 5.2: Service Provision and Control Planning and controlling service provision activities.

• Topic 5.3: Validation of Processes Validating production and service provision processes.

• Topic 6.1: Monitoring and Measurement Monitoring and measuring QMS performance.

• Topic 6.2: Analysis and Evaluation Analyzing and evaluating QMS data.

• Topic 6.3: Continual Improvement Implementing continual improvement activities.

• Topic 6.4: Corrective Action and Preventive Action Implementing corrective action and preventive action procedures.

• Topic 7.1: Auditing Principles and Techniques Understanding auditing principles and techniques.

• Topic 7.2: Audit Planning and Preparation Planning and preparing for audits.

• Topic 7.3: Conducting Audits Conducting audits and gathering evidence.

• Topic 7.4: Audit Reporting and Follow-up Reporting audit findings and implementing corrective actions.

• Topic 7.5: Certification and Surveillance Audits Understanding certification and surveillance audit requirements.

• Topic 8.1: Implementation Planning and Execution Planning and executing QMS implementation activities.

• Topic 8.2: Maintenance and Continual Improvement Maintaining and continually improving the QMS.

• Topic 8.3: Management Review and Evaluation Conducting management reviews and evaluations.

This course is designed to be interactive, engaging, comprehensive, personalized, up-to-date, practical, and focused on real-world applications.

Participants will have access to:

• High-quality content and expert instructors
• Certification upon completion
• Flexible learning options and user-friendly interface
• Mobile-accessible content and community-driven discussions
• Actionable insights and hands-on projects
• Bite-sized lessons and lifetime access
• Gamification and progress tracking features

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