Executive Development Programme in ISO 13485 Transformation
-- viewing nowThe 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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Course Details
• 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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Entry Requirements
- Basic understanding of the subject matter
- Proficiency in English language
- Computer and internet access
- Basic computer skills
- Dedication to complete the course
No prior formal qualifications required. Course designed for accessibility.
Course Status
This course provides practical knowledge and skills for professional development. It is:
- Not accredited by a recognized body
- Not regulated by an authorized institution
- Complementary to formal qualifications
You'll receive a certificate of completion upon successfully finishing the course.
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