OpenExamsFREE PRACTICE — ANY EXAM

PECB Certificate Holder in ISO 13485 Foundation — Requirements & Free Practice

US · License preparation

100 free questions · Answer explanations · No signup required

Loading selected examination banks…

Choose what to practice

Start with an exam below. Your examination requirements depend on your application pathway. View licensing requirements

Licenses, application pathways and examination requirements

Each license and applicant pathway has its own requirements and exemptions. Choosing practice questions does not determine your eligibility.

PECB Certificate Holder in ISO 13485 Foundation

Licensing authority: PECB

Initial by examination
PECB ISO 13485 Foundation Exam
Attendance
Be present at least 30 minutes before the session with valid identification; online delivery uses the PECB Exams application and remotely supervised camera. Foundation closed-book rules forbid reference material.
Award
Pass the Foundation exam, apply for the certificate, meet PECB application review and sign the PECB Code of Ethics. The award table requires no professional, MS audit/assessment or project experience; references and work experience are not required for Foundation certificates under the general policies.
Dates
No official commencement or examination retirement date was found in the current program page, linked brochure, English catalogue record or current rules. The course-update discontinuation notice is not an examination cessation notice. No PDF metadata or retrieval date is used as an effective date.
Delivery
Only the English online multiple-choice examination is in scope. The same catalogue row also permits paper delivery; that is not a separate examination. Partner-arranged sessions and online scheduling are subject to actual availability.
Fees And Retakes
The program includes examination and certificate fees in the training price. The current general policy includes an initial attempt and one free retake within its 12-month course-completion/purchase cycle; a failed initial attempt requires a 15-day wait. Actual prices and individual entitlements are not asserted.
Scheduling
After training, use the relevant course's Exam column in myPECB, select English and an available session, read the Exam Rules and Policies and Online Examinee Manual, then confirm scheduling. Sessions are published bi-weekly; fully booked sessions require another date. The requested 2026-11-25 through 2027-02-28 window is not a guaranteed appointment or reserved seat.
Training
Complete the PECB ISO 13485 Foundation training course; course prerequisites are None. The general no-specific-training policy expressly excepts Foundation Certificate Programs.

PECB ISO 13485 Foundation Exam

Provider
PECB
Format
English; online; multiple choice; closed book. The English catalogue also offers paper delivery of the same examination; only online delivery is investigated here.
Exam questions
Total questions: 40.
Time limit
1 hour
Examination outline
  • Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
  • Medical Devices Quality Management System (MDQMS)
Examination sources