ISO 13485 Lead Implementer - Self Study

ISO 13485 Lead Implementer – Self Study

This course includes:

  • Price £995.00 excluding VAT

Why should you attend

ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices. After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Implementer” credential. By holding a PECB Lead Implementer Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.

Who can attend:

  • 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

Educational approach:

  • This training is based on both theory and best practices used in the implementation of a MDQMS
  • Lecture sessions are illustrated with examples based on case studies
  • Practical exercises are based on a case study which includes role playing and discussions
  • Practice tests are similar to the Certification Exam

Course agenda:

  • Day 1: Introduction to ISO 13485 and initiation of a MDQMS

    Day 2: Plan the implementation of a MDQMS

    Day 3: Implementation of a MDQMS

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

    Day 5: Certification Exam

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