Advanced Certificate in ISO 13485: Mastery
-- viewing nowThe Advanced Certificate in ISO 13485: Mastery is a comprehensive course designed for professionals seeking expertise in the Quality Management System for medical devices. This certification emphasizes the importance of understanding and implementing ISO 13485 standards, ensuring compliance and fostering continuous improvement in the medical device industry.
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Course Details
• ISO 13485 Overview: Understanding the International Standard for Medical Devices
• Quality Management System (QMS) Development for ISO 13485 Compliance
• Risk Management in Medical Device Manufacturing: FMEA, FTA, and Hazard Analysis
• Document Control and Record Keeping in ISO 13485:2016
• Design Control and Validation for Medical Device Manufacturing
• Supplier Management and Control for ISO 13485 Certification
• Internal Auditing and Management Review for ISO 13485:2016
• Corrective and Preventive Action (CAPA) Implementation in Medical Device Manufacturing
• Validation of Processes, Equipment, and Software in ISO 13485 Environment
• Preparing for and Managing ISO 13485 Certification
Career Path
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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