ISO 13485 Lead Implementer Course Overview

Target Audience for ISO 13485 Lead Implementer

The ISO 13485 Lead Implementer course equips professionals with the skills to establish and manage a Medical Device Quality Management System (MDQMS).

• Quality Managers in the medical devices industry
• Regulatory Affairs Managers
• Medical Device Professionals and Consultants
• Compliance Officers
• Risk Managers
• Design and Development Engineers
• Internal Auditors and External Auditors specializing in medical device quality systems
• Product Managers in the medical device sector
• R&D Managers in medical devices companies
• Suppliers and Manufacturers of medical devices
• Professionals responsible for implementing ISO 13485
• Individuals seeking a comprehensive understanding of MDQMS requirements
• Project Managers overseeing MDQMS implementation
• Top Management members responsible for the quality of medical devices

Learning Objectives - What you will Learn in this ISO 13485 Lead Implementer?

Introduction to the Course's Learning Outcomes and Concepts Covered:

This ISO 13485 Lead Implementer course aims to provide participants with comprehensive knowledge and skills to implement, manage, and maintain a Medical Devices Quality Management System (MDQMS) in accordance with ISO 13485 standards.

Learning Objectives and Outcomes:

• Understand ISO 13485: Grasp the purpose, content, and correlation between ISO 13485, regulatory requirements, and other quality management system standards.
• MDQMS Implementation: Learn to initiate, plan, and lead the implementation of a MDQMS in a medical device organization.
• Regulatory Framework: Comprehend the medical device regulatory framework to ensure the MDQMS aligns with global compliance requirements.
• Quality Management Principles: Understand the quality management principles specific to medical devices and apply them within the MDQMS.
• Gap Analysis and Planning: Conduct a gap analysis of current systems and plan the implementation of MDQMS, ensuring alignment with organizational objectives.
• Documentation and Controls: Define and manage the documentation process, design controls, and drafting procedures within the MDQMS.
• Risk Management: Incorporate risk management principles into the MDQMS to ensure product safety and efficacy.
• Internal Audits and Management Reviews: Conduct effective internal audits, management reviews, and address non-conformities systematically.
• Continuous Improvement: Implement continuous improvement processes, monitor MDQMS performance, and prepare for certification audits.
• Certification Preparation: Equip with the knowledge and skills necessary to successfully prepare for and achieve ISO 13485 certification.