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. 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.

How this course works

Self-study means taking the training course at your own pace and in a place of your choice, for which all that is needed is access to the PECB training course materials. PECB describes this format as suitable for participants with considerable knowledge of the subject who do not require assisted lecturing.

• The complete PECB course material, digitally, through my PECB
• Work through it at your own pace, wherever you choose
• You direct your own studying — this format includes no taught sessions
• The same exam and the same credential as any other PECB format
• Around 450 pages of information and practical examples

You have 12 months from the date of purchase to work through the course and sit the exam — there are no fixed dates and nothing to schedule. Whichever format you take, PECB delivers the course material digitally through my PECB, and you sit the exam online from anywhere in the world once you are ready.

Your fee covers PECB’s full certification cycle:

• The first exam attempt
• One free retake
• The certification application fee
• The first year of PECB's Annual Maintenance Fee (AMF)

Both the 12-month window and what the fee covers are set by PECB’s Exam Rules and Policies. Note the last item: PECB covers the first year of its Annual Maintenance Fee, so keeping the credential current after that first year is paid to PECB directly.

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

What you’ll be able to do

• 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 outline

PECB structures the course in 5 parts, covering 5days’ worth of material. You work through them in your own time.

1. Introduction to ISO 13485 and initiation of a MDQMS

2. Plan the implementation of a MDQMS

3. Implementation of a MDQMS

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

5. Certification Exam

Prerequisites

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

Exam & certification

The course closes with the PECB Certified ISO 13485 Lead Implementer Exam, which meets the requirements of PECB’s Examination and Certification Programme and covers 7 competency domains:

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

Pass it and you can apply for the PECB Certified ISO 13485 Lead Implementer credential. Passing the exam is only part of what PECB asks: each rung of the ladder adds experience, and every one of them requires signing the PECB Code of Ethics.