Improve your experience. We are very sorry but this website does not support Internet Explorer. We recommend using a different browser that is supported such as Google Chrome or Mozilla Firefox.

ISO 13485 Lead Implementer

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.

Description

 

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. 

About This Course

 

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

 

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

Assessment

 

The “PECB Certified ISO 13485 Lead Implementer” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency domains:

  • Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
  • Domain 2: Medical Devices Quality Management System (MDQMS)
  • Domain 3: Planning a MDQMS implementation based on ISO 13485
  • Domain 4: Implementing a MDQMS based on ISO 13485
  • Domain 5: Performance evaluation, monitoring and measurement of a MDQMS based on ISO 13485
  • Domain 6: Continual improvement of a MDQMS based on ISO 13485
  • Domain 7: Preparing for a MDQMS certification audit

For specific information about exam type, languages available, and other details, please visit the List of PECB Exams and the Examination Rules and Policies.

 

Prerequisites

 

A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.

What's Included?

 

  • Certification fees are included on the exam price
  • Training material containing over 450 pages of information and practical examples will be distributed
  • An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
  • In case of exam failure, you can retake the exam within 12 months for free

Who Should 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

Similar courses

ISO 9001Foundation

PECB's Official ISO 9001 Foundation Training Course

More Information
ISO 9001 Lead Implementer

PECB's Official ISO 9001 Lead Implementer Training Course

More Information
ISO 9001 Lead Auditor

PECB's Official ISO 9001 Lead Auditor Training Course

More Information
ISO 13485 Quality Management Foundation

ISO 13485 determines the requirements for the medical devices industry. This standard was established to be used by companies during the life cycle of medical devices, from the production to post-production, including decommission and disposal.

More Information
ISO 13485 Lead Auditor

ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques.

More Information

Press enter to see more results