Home CertificationISO 13485 Lead Implementer
ISO 13485 Lead Implementer Certification
This certification offers a comprehensive overview of ISO 13485, focusing on the essential requirements for establishing and maintaining a quality management system for medical devices.
It covers the key clauses of the standard, including management responsibilities, resource management, risk management, and product realization. Additionally, delegates will learn about the implementation phases, auditing processes, and the relationship between ISO 13485 and ISO 9001. Practical exercises and examples are integrated throughout the modules to provide hands-on understanding and application of the standards in the medical device industry.
What You Will Learn?
ISO 13485 Lead Implementer Certification offers numerous benefits, including enhanced career prospects and recognition as a professional capable of leading the implementation of quality management systems in the medical device industry. Certified professionals are equipped with the skills to establish, monitor, and continuously improve ISO 13485-compliant systems. This certification boosts credibility and demonstrates expertise in regulatory requirements, helping organizations maintain compliance and improve their processes effectively.
• Introduction to ISO 13485:2016
• Implementation Phases of the ISO 13485 Frameworks
• Internal Auditing
• Internal Audit Evidence and Findings
• ISO 13485 and Quality Management Systems
• Fundamentals of Quality Management Systems
• Risk Management
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