Advanced Certificate in ISO 13485: Unlock Your Potential
-- viewing nowThe Advanced Certificate in ISO 13485 is a comprehensive course designed to equip learners with the essential skills needed to excel in the medical device industry. This certification course focuses on ISO 13485, an internationally recognized standard for quality management systems specific to the medical device industry.
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Course Details
• Introduction to ISO 13485: Understanding the Standard & Its Importance
• Key Changes & Updates in ISO 13485:2016
• Establishing & Implementing Quality Management System for Medical Devices
• Risk Management in Medical Device Manufacturing: ISO 14971 Integration
• Documentation Control & Record Keeping in ISO 13485 Compliance
• Managing Supplier Relationships in Medical Device Manufacturing
• Internal Auditing & Management Review: ISO 13485 Requirements
• Implementing Corrective & Preventive Action Processes
• Preparing for ISO 13485 Certification: Tips & Best Practices
• Continual Improvement & Maintaining ISO 13485 Compliance
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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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