PECB ISO 13485 Foundation
PECB ISO 13485 Foundation Exam
More study resources
Cheat sheet
Keep the key ideas within reach.
ExploreKey terms
Get comfortable with the vocabulary.
ExploreStudy plan
Give each week a clear focus.
ExploreCommon mistakes
Understand the traps and how to avoid them.
ExploreCase studies
Put your knowledge to work in context.
ExploreExam-day guide
Prepare for the day ahead.
ExploreAbout this exam
The PECB ISO 13485 Foundation credential is an entry-level certificate for people who need to understand the basic elements of implementing and managing a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. PECB describes the two-day training course as covering the different modules of an MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement. It is aimed at individuals involved in medical devices quality management, those seeking knowledge about the main processes of an MDQMS, and those interested in pursuing a career in the field. There are no prerequisites, and no professional experience, audit or project experience is required to apply for the certificate; the only other requirement is signing the PECB Code of Ethics. To earn the designation you must pass the PECB ISO 13485 Foundation Exam, which covers two competency domains: fundamental principles and concepts of an MDQMS, and the MDQMS itself. Preparation typically follows the course structure: Day 1 introduces MDQMS concepts as required by ISO 13485, and Day 2 covers MDQMS requirements plus the certificate exam. The educational approach combines lecture sessions illustrated with practical questions and examples, practical exercises with discussions, and practice tests similar to the certificate exam. Note that PECB states updates to this training course have been discontinued, and a new version might be available upon request.
What you'll study
About PECB ISO 13485 Foundation preparation
Do I need any prior experience or qualifications to take the ISO 13485 Foundation exam?
No. PECB lists the prerequisites for the training course as none, and the certificate requirements show no professional experience, MS audit/assessment experience or project experience. The only additional requirement is signing the PECB Code of Ethics after passing the exam.
What does the exam cover?
PECB states the exam covers two competency domains: Domain 1, fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS), and Domain 2, Medical Devices Quality Management System (MDQMS). The course itself addresses MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.
How long is the training course, and how is it structured?
It is a two-day course. Day 1 covers introduction to MDQMS concepts as required by ISO 13485; Day 2 covers MDQMS requirements and includes the certificate exam. Lecture sessions are illustrated with practical questions and examples, and practical exercises include examples and discussions.
Are practice tests similar to the real exam?
Yes, PECB states that practice tests used in the course are similar to the Certificate Exam. They are a useful way to check your grasp of both domains before sitting the real exam, and they are part of the stated educational approach alongside lectures and practical exercises.
What happens if I fail the exam?
PECB states that in case of exam failure, you can retake the exam within 12 months for free. Plan your retake inside that window and use the practice tests and course material to close the gaps identified by your first attempt.
Is the exam fee separate from the training price?
According to PECB, certificate and examination fees are included in the price of the training course. PECB does not publish a standalone exam fee on this course page, so confirm any separate pricing directly with PECB or your training partner before enrolling.
How many CPD credits do I get for attending?
An attestation of course completion worth 14 CPD (Continuing Professional Development) credits is issued to participants who have attended the training course. Note that this is for attendance; the certificate itself requires passing the PECB ISO 13485 Foundation Exam.
In what order should I study the material?
Follow the course sequence: first the fundamental principles and concepts of an MDQMS as required by ISO 13485, then the MDQMS requirements themselves. That matches the two exam domains and the two training days, so concepts are in place before you work through requirement-by-requirement content.
What is a common reason candidates struggle?
Candidates often memorise clause lists without understanding how MDQMS elements connect, such as how management commitment, internal audit, management review and continual improvement feed each other. Because the exam spans both concepts and requirements, study the relationships between modules rather than isolated definitions.
Is this course still being updated?
PECB states that updates to this training course have been discontinued and that a new version of the training course might be available upon request. If you want the most current materials, contact PECB at [email protected] before enrolling.