Overview
This course provides a comprehensive understanding of the ISO 13485:2016 standard, which focuses on establishing a robust Quality Management System (QMS) for the medical device industry. Participants will learn the key requirements of ISO 13485:2016, including risk management, process controls, and regulatory compliance. The course covers the essential aspects of implementing a QMS that ensures product quality and patient safety throughout the product lifecycle.
This training is designed to help medical device manufacturers align their operations with ISO 13485:2016. The course ensures organizations can achieve certification and realize a return on investment through better resource management and compliance.
Key Benefits
- Understand ISO 13485:2016 requirements for medical devices
- Improve product quality and ensure patient safety
- Gain insights into risk management and process controls
- Enhance compliance with global medical device regulations
Course Objectives
- Learn how to implement ISO 13485:2016 for medical devices
- Identify and mitigate risks associated with medical device manufacturing
- Prepare for audits and certification by understanding key ISO 13485:2016 processes and requirements
Duration
Certification
Participants will receive a course completion certificate upon successful completion.