ISO 13485 Lead Implementer

ISO 13485 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining a Medical Devices Quality Management System (MDQMS) based on ISO 13485, with a thorough understanding of its best practices. After passing the exam, you can apply for the “PECB Certified ISO 13485 Lead Implementer” credential.

Who should attend?

• Managers or consultants involved in Medical Devices Quality Management
• Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
• Individuals responsible for maintaining conformity with MDQMS requirements
• MDQMS team members

Course agenda

• Day 1 — Introduction to ISO 13485 and initiation of an MDQMS
• Day 2 — Planning the implementation of an MDQMS
• Day 3 — Implementation of an MDQMS
• Day 4 — MDQMS monitoring, measurement, continual improvement and preparation for the certification audit
• Day 5 — Certification exam

Learning objectives

• Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
• Master the concepts, approaches, methods and techniques used to implement and manage an MDQMS
• Interpret the ISO 13485 requirements in the specific context of an organization
• Support an organization to plan, implement, manage, monitor and maintain an MDQMS

Examination

Exam duration: 3 hours.

General information

• More than 450 pages of training materials, including practical examples, exercises and quizzes.
• An attestation of course completion worth 31 CPD (Continuing Professional Development) credits.

Languages: available in English and French. For another language, send us a request and we will check availability.