ISO 13485 Foundation

ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.

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 200 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

• Individuals involved in Medical Devices Quality Management
• Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS)
• Individuals interested to pursue a career in Medical Devices Quality Management

What you’ll be able to do

• Understand the elements and operations of a Medical Devices Quality Management System (MDQMS)
• Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
• Understand the approaches, methods and techniques used for the implementation and management of a MDQMS

Course outline

PECB structures the course in 2 parts, covering 2days’ worth of material. You work through them in your own time.

1. Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485

2. Medical Devices Quality Management System requirements and Certificate Exam

Prerequisites

None.

Exam & certification

The course closes with the PECB ISO 13485 Foundation Exam, which meets the requirements of PECB’s Examination and Certification Programme and covers 2 competency domains:

1. Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
2. Medical Devices Quality Management System (MDQMS)

Pass it and you can apply for the PECB Certificate Holder in ISO 13485 Foundation credential. There is no professional-experience requirement — the training course, the exam, and signing the PECB Code of Ethics are the whole of it.