Medical Devices Quality Mgt. Systems

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Medical Devices Quality Mgt. Systems


Medical device manufacturing is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce and place onto the market medical devices that are safe and fit for their intended purpose.

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.


  • Increase efficiency, cut costs and monitor supply chain performance.
  • ISO 13485 certification helps you improve your products and processes.
  • Meet customer and regulatory requirements.

Who this course applies to:

  • Managers or consultants involved in Medical Devices Quality Management
  • Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
  • Individuals responsible for maintaining conformance with MDQMS requirements
  • MDQMS team members

Learning Objectives

  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
  • Learn how to interpret the ISO 13485 requirements in the specific context of an organization
  • Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
  • Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices

Structure of training

Day 1 – Introduction to ISO 13485 and initiation of a MDQMS

  • Course objectives and structure
  • Standard and regulatory framework
  • Medical Devices Quality Management System (MDQMS)
  • Fundamental principles of quality and medical devices
  • Initiating the MDQMS implementation

Day 2 – Plan the implementation of the MDQMS

  • Understanding the organization and clarifying the quality objectives
  • Analysis of the existing management system
  • Leadership and approval of the MDQMS project
  • MDQMS scope
  • Quality Policy
  • Definition of the organizational structure

Day 3 – Implementation of a MDQMS

  • Definition of the document management process
  • Design of controls and drafting procedures
  • Communication plan
  • Training and awareness plan
  • Product Realization
  • Operations Management

Day 4 – MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit

  • Monitoring, measurement, analysis and evaluation
  • Internal audit
  • Management review
  • Treatment of problems and non-conformities
  • Improvement
  • Preparing for the certification audit
  • Competence and evaluation of implementers
  • Closing the training

Day 5 – Certification Exam

Additional Information
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Dec 13 2022

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