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ISO 13485 Lead Implementer Course Overview

The ISO 13485 Lead Implementer Course Overview by PECB equips professionals with the skills to develop and maintain an effective quality management system for medical devices. This course is crucial for quality managers, compliance officers, and healthcare professionals seeking to enhance their expertise in regulatory requirements and improve organizational processes, ensuring safety and efficacy in medical device production.


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Course Introduction

Price:

USD 2,550

Duration:

40 Hrs.

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  • Introduction to ISO 13485
    • Overview of ISO 13485 and its importance in the medical device industry
    • Key concepts and definitions
  • Understanding the Quality Management System (QMS)
    • Principles of quality management
    • Structure and requirements of ISO 13485:2016
  • Planning and Preparing for Implementation
    • Gap analysis and initial assessment
    • Defining the scope of the QMS
    • Establishing objectives and metrics
  • Implementing the QMS
    • Documentation requirements and control
    • Risk management principles in medical devices
    • Roles and responsibilities of personnel
  • Auditing and Monitoring the QMS
    • Internal audit processes and techniques
    • Management review and performance evaluation
    • Continuous improvement strategies
  • Compliance and Regulatory Requirements
    • Overview of regulatory requirements related to medical devices
    • Understanding the importance of conformity assessment
  • Case Studies and Practical Applications
    • Real-world examples of ISO 13485 implementation
    • Lessons learned and best practices
  • Preparing for Certification
    • Steps to achieve ISO 13485 certification
    • Selecting a certification body and audit process
  • Conclusion and Next Steps
    • Summary of key takeaways
    • Resources for further learning and support

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