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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โข Introduction to ISO 13485 & Medical Device Quality Management System
โข Benefits & Challenges of ISO 13485 Transformation
โข Regulatory Framework & Compliance in ISO 13485
โข Gap Analysis & Implementation Planning for ISO 13485
โข Key Elements of ISO 13485: Management Responsibility, Resource Management, Product Realization, Measurement, Analysis and Improvement
โข Risk Management in ISO 13485 Transformation
โข Documentation Control & Record Keeping in ISO 13485
โข Internal Audit & Management Review for ISO 13485
โข Preparing for & Executing ISO 13485 Certification Audit
โข Continuous Improvement in ISO 13485 & Maintaining Certification
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