PECB Certified Course: ISO 13485 Foundation
499.50ر.س
999ر.س-50%Product description
Build a practical introduction to quality management systems for medical devices.
This Foundation course introduces the structure and principal processes of a medical devices quality management system based on ISO 13485. It connects policy, documented procedures, management responsibility, performance measurement, internal audit, management review and continual improvement within a regulated medical-device context.
Course at a glance
- Provider and awarding body: PECB.
- Learning format: PECB Self-Study (official course materials).
- Language: English.
- Level: Foundation.
- Examination and certification-application cycle: 12 months from purchase for the first examination attempt, the included free retake if needed, and the certification application.
What this course includes
- More than 200 pages of official PECB instructional materials containing explanations, guidance and practical examples.
- The first examination attempt and one free retake.
- The certification-application fee and the first year of the Annual Maintenance Fee, where applicable.
- A course-completion attestation worth 14 CPD credits, separate from the PECB professional credential.
What you will learn
After completing the course, the learner should be able to:
- explain the main elements and operation of an MDQMS;
- describe how ISO 13485 relates to relevant standards and regulatory frameworks;
- recognize common approaches used to implement and manage an MDQMS.
Who this course is for
- People involved in medical-device quality management.
- Professionals seeking an introduction to MDQMS processes.
- Individuals considering a career or advanced pathway in medical-device quality.
Prerequisites: PECB states that no prerequisites apply to this Foundation course.
Course outline
- Day 1 : Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485
- Day 2 : Medical Devices Quality Management System requirements and Certificate Exam
Exam and credential pathway
The exam addresses the fundamental principles and concepts of an MDQMS and the management-system requirements covered by ISO 13485.
After passing the exam, the candidate may apply for the PECB Certificate Holder in ISO 13485 Foundation designation. The official Foundation pathway lists no professional, audit or project-experience requirement, while application and ethics requirements remain applicable.
Course completion, examination success, certification application and credential issuance are separate stages; the credential is not issued automatically.
For official course details, see the PECB ISO 13485 Foundation page.
Access and activation
The 12-month period for the first examination, included free retake and certification application begins on the purchase date.
Each order covers one learner. Wadi Solutions begins processing the PECB registration within one business day, and activation details are sent to the learner's email. Required enrolment details are shared with PECB for activation.
Continue your learning path
Explore ISO 13485 — Medical device quality courses to see the available options.
Before you buy
- If you do not have a myPECB account, create one here.
- If your myPECB email differs from the email used for your Wadi Solutions order, add your myPECB email to the order notes.
