Executive Development Programme in ISO 13485 Transformation
-- ViewingNowThe Executive Development Programme in ISO 13485 Transformation is a certificate course designed to equip learners with the necessary skills to implement and manage ISO 13485 quality management systems in medical device organizations. This course is essential for professionals seeking to advance their careers in the medical device industry, where compliance with ISO 13485 is a critical requirement.
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⢠Introduction to ISO 13485 & Medical Device Quality Management System
⢠Benefits & Challenges of ISO 13485 Transformation
⢠Regulatory Framework & Compliance in ISO 13485
⢠Gap Analysis & Implementation Planning for ISO 13485
⢠Key Elements of ISO 13485: Management Responsibility, Resource Management, Product Realization, Measurement, Analysis and Improvement
⢠Risk Management in ISO 13485 Transformation
⢠Documentation Control & Record Keeping in ISO 13485
⢠Internal Audit & Management Review for ISO 13485
⢠Preparing for & Executing ISO 13485 Certification Audit
⢠Continuous Improvement in ISO 13485 & Maintaining Certification
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