PECB Certified Course: ISO 13485 Lead Implementer

Plan and guide an ISO 13485 quality management system from initiation to audit readiness.

This advanced implementation course develops the knowledge needed to establish, operate, monitor and improve a medical devices quality management system based on ISO 13485. It follows the implementation lifecycle from context and planning through operational controls, performance evaluation, continual improvement and preparation for a certification audit.

Course at a glance

• Provider and awarding body: PECB.
• Learning format: PECB Self-Study (official course materials).
• Language: English.
• Level: Lead Implementer.
• 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 450 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 31 CPD credits, separate from the PECB professional credential.

What you will learn

After completing the course, the learner should be able to:

• interpret ISO 13485 requirements in an organizational context;
• plan and initiate an MDQMS implementation;
• support the operation, monitoring and continual improvement of the system;
• prepare the MDQMS for a certification audit.

Who this course is for

• Managers and consultants involved in medical-device quality management.
• Implementation advisers and MDQMS project leaders.
• People responsible for maintaining conformity with ISO 13485 requirements.
• Members of an MDQMS implementation or management team.

Prerequisites: PECB expects a fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.

Course outline

• Introduction to ISO 13485 and initiation of an MDQMS
• Planning the implementation of an MDQMS
• Implementation of an MDQMS
• MDQMS monitoring, measurement, continual improvement and preparation for a certification audit
• Certification exam

Exam and credential pathway

The exam covers MDQMS principles and requirements, implementation planning and execution, performance evaluation, continual improvement and preparation for a certification audit.

Passing the course examination enables an application to the applicable PECB ISO 13485 Implementer pathway. The awarded designation depends on meeting the relevant professional and MDQMS project-experience requirements, together with the application and ethics requirements.

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 Lead Implementer 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

• ISO 13485 Foundation
• ISO 13485 Lead Auditor

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.