Day 1:Introduction to ISO 13485 and initiation of a MDQMS

Day 2: Plan theimplementation of a MDQMS

Day 3:Implementation of a MDQMS

Day 4: MDQMSmonitoring, measurement, continuous improvement and preparation for acertification audit

Day 5: CertificationExam

• 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 conformance with MDQMS requirements
• MDQMS team members

ISO 13485 Lead Implementer trainingenables you to develop the necessary expertise to support an organization inestablishing, implementing, managing and maintaining a Medical Devices QualityManagement System (MDQMS) based on ISO 13485. During this training course, youwill also gain a thorough understanding of the best practices of MedicalDevices Quality Management Systems and be able to improve an organization`soverall performance by consistently providing safe and qualitative medicaldevices.

After mastering all the necessaryconcepts of Medical Devices Quality Management Systems, you can sit for theexam and apply for a “PECB Certified ISO 13485 Lead Implementer” credential. Byholding a PECB Lead Implementer Certificate, you will be able to demonstratethat you have the practical knowledge and professional capabilities to implementISO 13485 in an organization. 

• Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks 
• Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS
• Learn how to interpret the ISO 13485 requirements in the specific context of an organization
• Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS
• Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices