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ISO 13485 Foundation Certification
This certification provides a detailed introduction to ISO 13485, emphasizing its importance and the key requirements for establishing a quality management system for medical devices. Delegates will explore the general requirements, documentation, management responsibilities, and risk management principles.
The certification covers the stages of implementation, including gap analysis and process mapping, and the auditing process for ISO 13485 certification. Additionally, the relationship between ISO 13485 and ISO 9001 will be examined, highlighting the differences and similarities, along with the focus on continual improvement.
What You Will Learn?
ISO 13485 Foundation Certification provides a strong foundation in quality management systems for medical devices, enhancing career opportunities by demonstrating knowledge of essential regulatory standards. It helps individuals gain a deeper understanding of ISO 13485 requirements, enabling them to contribute to the implementation and maintenance of compliant systems.
The certification also enhances credibility, making professionals valuable assets to organizations seeking to ensure product safety and regulatory compliance in the medical device industry.
• Introduction to ISO 13485:2016
• An Overview of ISO 13485:2016 Requirements
• Implementation Phases of the ISO 13485 Frameworks
• Conducting an ISO 13485 Certification Audit
• The Relationship Between ISO 13485 and ISO 9001
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