Content & Agenda

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.

Fee includes the cost of self-study training, as well as examination and certification by PECB ($700 Value!).

Delivery Format

Self-study at your desk, delivered through KATE training application. Participants will be provided with the training course material containing over 450 pages of explanatory information, examples, best practices, exercises, and quizzes.

Prerequisites

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

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

Examination

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

General Information

1. Certification fees are included on the exam price.

2. Training material containing over 450 pages of information and practical examples will be distributed.

3. An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.

4. In case of exam failure, you can retake the exam within 12 months for free.

Learn more on this course at ISO 13485 Lead Implementer Training