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. During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices.

• 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

Day 1 Introduction to ISO 13485 and initiation of a MDQMS

1. Course objectives and structure
2. Standard and regulatory framework
3. Medical Devices Quality Management System (MDQMS)
4. Fundamental principles of quality and medical devices
5. Initiating the MDQMS implementation

Day 2 Plan the implementation of the MDQMS

1. Understanding the organization and clarifying the quality objectives
2. Analysis of the existing management system
3. Leadership and approval of the MDQMS project
4. MDQMS scope
5. Quality Policy
6. Definition of the organizational structure

Day 3: Implementation of a MDQMS

1. Definition of the document management process
2. Design of controls and drafting procedures
3. Communication plan
4. Training and awareness plan
5. Product Realization
6. Operations Management

Day 4 MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit

1. Monitoring, measurement, analysis and evaluation
2. Internal audit
3. Management review
4. Treatment of problems and non-conformities
5. Improvement
6. Preparing for the certification audit
7. Competence and evaluation of implementers
8. Closing the training

Day 5 Certification Exam

• Higher Salary: Earn 20% more salary than non-certified professionals in the field
• Greater Responsibilities: Enhance your performance with additional responsibilities in the organization
• Diverse Job Roles: Broaden your scope at the organization as compared to your peers
• Global Recognition: Global recognition across different domains and industries with this certificate
• Versatile Opportunities: Land your dream job in a large organization with great expertise
• Sophisticated Skillsets: Validates the advanced experience, skills, and knowledge gained by professionals

1. Managers or consultants involved in Medical Devices Quality Management
2. Expert advisors seeking to master the implementation of a Medical Devices Quality Management System
3. individuals responsible for maintaining conformance with MDQMS requirements
4. MDQMS team members

A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles.

Being an ISO 13485-certified professional imposes your determination to offer qualitative products and services to your company and/or clients. Attaining the necessary knowledge and skills to operate an ISO 13485 framework demonstrates your commitment to helping your company ensure continuous improvement and better work processes.

It also indicates that you understand the importance of the safety and performance of medical devices and how a medical devices quality management system can assure just that, consequently leading to customer satisfaction. Similarly, it can introduce you to new opportunities, such as working for large companies that offer quality products and services. These companies will value your knowledge and expertise on this standard while enabling you to maximize your earning potential.

Here are some of the roles that benefit from ISO 13485 Lead Implementer certification in the Dubai region (as observed in popular job portals):

• Quality Manager - Responsible for overseeing the implementation and maintenance of a robust Medical Devices Quality Management System (MDQMS) based on ISO 13485, ensuring adherence to regulatory requirements and continuous improvement of quality processes.
• Regulatory Affairs Specialist - Ensures compliance with medical device regulations, prepares and submits regulatory documentation, and stays updated on changing regulatory landscapes to ensure conformity with ISO 13485 and other relevant standards.
• Compliance Officer - Manages and monitors adherence to ISO 13485 requirements, conducts internal audits, identifies areas for improvement, and ensures the organization maintains compliance with applicable regulations and quality standards.
• Quality Assurance Engineer - Works closely with cross-functional teams to develop, implement, and maintain quality control processes, performs risk assessments, and ensures compliance with ISO 13485 to meet product quality objectives.
• Consultant - Provides expert guidance and support to organizations seeking to implement ISO 13485-compliant quality management systems, conducts audits, offers recommendations for improvement, and assists in achieving and maintaining certification.

• The passing score for the ISO 13485 Lead Implementer exam is set at 70%.

• Duration: 3 hours
• Exam type: essay type
• Open book

• Pursuing this certification broadens the scope of individuals looking for career opportunities in this field.