Executive Development Programme in ISO 13485: A Practical Approach
-- ViewingNowThe Executive Development Programme in ISO 13485: A Practical Approach is a certificate course designed to empower professionals with the necessary skills to implement and manage ISO 13485 quality management systems in medical device organizations. This course is vital for professionals seeking to advance their careers in the medical device industry, where quality management is essential for regulatory compliance and product safety.
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⢠Introduction to ISO 13485 & Medical Device Quality Management System
⢠Benefits and Challenges of ISO 13485 Implementation
⢠Understanding Regulatory Requirements for Medical Devices
⢠Key Elements and Components of ISO 13485:2016
⢠Development, Production, Installation and Servicing of Medical Devices
⢠Risk Management in ISO 13485: A Practical Approach
⢠Quality Planning, Monitoring, Measurement, and Analysis in ISO 13485
⢠Documentation Requirements and Control in ISO 13485
⢠Internal Audit and Management Review of Quality Management System
⢠Continuous Improvement and Corrective Action in ISO 13485
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