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Duration: 180 Days

Fees: 225 US$

Course duration is the Learning Management System (LMS) access available to the student. However, the student can complete the course early or whenever within 180 days and appear for the exam as per the individual learning goals.

Eligibility criteria:

  • Knowledge of ISO 13485 -Medical Device-Quality Management System

Course material:

  • PowerPoint Presentations
  • Reference material
  • Articles
  • Case Studies
  • Case Reference Material
  • Management System Documentation Templates
  • Videos

Assessment method:

  • Assignments
  • Examination

Career Prospects: Medical Devices Industry

  • Quality System Engineer
  • QM/QA Specialist
  • Quality Analyst
  • Operation Manager
  • Medical Device - Quality Management System Consultant

Certified Lead Implementer - ISO 13485 Medical Device - Quality Management System


Lead Implementer - ISO 13485:2016

  • A course intended to prepare professionals to successfully implement a QMS audit for Medical devices conforming to the ISO 13485 framework. By implementing the ISO 13485 standard, manufacturers and suppliers can improve their reliability rating in the marketplace. The certification verifies that the client organization conforms to the ISO 13485 standards; and the medical devices produced are superior, not just in quality but also in safety measures.
  • Empirical approach to coaching will include detailed training material, assignments, case studies and presentations to assist students in analysis and synthesis of body of knowledge and to develop required skills.
  • On course completion, you can appear for the exam to qualify for Credentials Global’s ISO 13485 Lead Implementer certification.
  • This course is open to professionals, technical specialists, MDQMS team members, managers and leaders that seek to spearhead the implementation of and ensure conformity to ISO 13485 standards.

Key Outcomes:

  • Understand the correlation between international regulations, standards and ISO 13485
  • Acquire the skills to interpret the ISO 13485 standard and apply it to specific business issues in an organization
  • Grasp the strategy to organize, implement, sustain and refine QMS for medical devices with compliance to the ISO 13485 framework for an organization
  • Build competence to guide and support organizations to implement best practices in line with the ISO 13485 framework
  • Identify requirements for ensuring compliance with ISO 13485 standards
  • Improve process efficiency from blueprint to delivery stage for medical devices
  • Analyse findings from the audit and initiate reforms.

Course Chapters:

  • Chapter 1 Introduction to Course
  • Chapter 2 High Level Structure
  • Chapter 3 Introduction to Standard & Related Terms and definition
  • Chapter 4 Process Mapping.
  • Chapter 5 Quality management system
  • Chapter 6 Management responsibility
  • Chapter 7 Resource management
  • Chapter 8 Product Realization I
  • Chapter 9 Product Realization II
  • Chapter 10 Product Realization III
  • Chapter 11 Product Realization IV
  • Chapter 12 Competence and Awareness and Organizational Communication
  • Chapter 13 Monitoring measurement and Data Analysis
  • Chapter 14 Performance Evaluation
  • Chapter 15 Improvement
  • Chapter 16 Managing Management System Implementation Project
  • Chapter 17 Consulting Skills for Management System Implementation

Certified Lead Implementer - ISO 13485 Medical Device - Quality Management System e training online