ISO 13485 Lead Implementer

4.5/5

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. 

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Training Options

Classroom Training

Online Instructor Led

Onsite Training

Course Information

  • 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

General Information:

  • Certification and examination fees are included in the price of the training course
  • 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

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

Audience Profile

  • 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

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    Corporate Training Options

    Online Instructor Led

    Live, Online Training by top Instructors and practitioners across the globe.

    Onsite
    Training

    Conduct training at the work location you desired.

    Classroom Training

    The Venue will be ideally located and easy to access with covid-19 SOP's.

    Overseas Training

    Travel to any desired location for your training.

    What People say?

    Mohammed Aljbreen Operation Specialist, SAMA

    The Clarity of the Content was very good. The explanation of the trainer with in-depth knowledge in a proper flow really impressed me to give 5 star rating.

    Arindam Chakraborty Systems Specialist, King Abdullah University of Sciences & Technology

    The Instructor was really impressive. Clear cut explanation of every topic he covered with real time scenarios.

    Sher Afzal Khan Cloud Engineer, Cloud 9 Networks

    The Trainer and the Course Material, both are good. Good flow of explanation with simple examples. The complete training was focused on current industry challenges.

    Jawed Ahmad Siddiqui Sr. System Administrator, Saudi Ceramics

    The Trainer’s presentation was impressed me to continue the course till end. Never feel bore till the entire sessions. She studied our mindset and follows.

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