ISO 13485 Lead Implementer Course Overview

ISO 13485 Lead Implementer Course Overview

The ISO 13485 Lead Implementer course is a comprehensive training program designed to equip learners with the knowledge and skills necessary to implement and manage a Medical Devices Quality Management System (MDQMS) based on ISO 13485. This standard outlines requirements for a quality management system specific to the medical devices industry, focusing on safety and efficiency throughout the product lifecycle.

Throughout the course, participants will engage with a structured curriculum starting with an introduction to ISO 13485 and the initiation of a MDQMS. Learners will delve into the standard and regulatory framework, understand the fundamental principles of quality and medical devices, and begin planning the MDQMS implementation by clarifying quality objectives and analyzing existing systems.

Subsequent modules guide learners through the processes of designing and implementing the MDQMS, ensuring compliance with ISO 13485, and preparing for the certification audit. The course emphasizes practical skills such as drafting procedures, developing a communication plan, managing product realization, and conducting internal audits.

By completing the ISO 13485 training course, professionals will be able to assure that their organizations meet the stringent quality specifications demanded by the medical devices industry, leading to enhanced product quality, improved patient safety, and increased market access. The final modules include a certification exam, which upon passing, confirms the individual's competence as an ISO 13485 Lead Implementer, ready to drive continual improvement within their organization's ISO 13485 quality management system.

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  • Live Online Training (Duration : 40 Hours)
  • Per Participant
  • Include Exam

♱ Excluding VAT/GST

Classroom Training price is on request

You can request classroom training in any city on any date by Requesting More Information

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Course Prerequisites

To ensure the successful completion of the ISO 13485 Lead Implementer course, participants should have the following minimum prerequisites:

  • A basic understanding of quality management principles and concepts, particularly as they apply to medical devices.
  • Familiarity with the ISO 13485 standard or other quality management system standards.
  • Experience in or exposure to quality management processes and medical device regulatory requirements.
  • The ability to comprehend and analyze complex documents and standards.
  • Good communication and analytical skills to participate actively in the training discussions and exercises.

Please note that while these prerequisites are recommended, they are not designed to exclude interested participants with a strong desire to learn and improve their skills in the medical device quality management system domain. Our course is structured to accommodate varying levels of prior knowledge, and our skilled instructors are adept at assisting participants to bridge gaps in understanding.

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.