Global Certificate in ISO 13485 for Device Manufacturers
-- viewing nowThe Global Certificate in ISO 13485 for Device Manufacturers is a comprehensive course designed to empower professionals in the medical device industry. This certification focuses on ISO 13485, an internationally recognized standard for quality management systems specific to medical devices.
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Course Details
• Introduction to ISO 13485 & Medical Device Quality Management Systems
• Understanding Regulatory Requirements for Medical Device Manufacturing
• Key Principles & Clauses of ISO 13485:2016
• Implementing & Managing Quality Processes in Medical Device Manufacturing
• Risk Management in Medical Device Manufacturing: ISO 14971 Integration
• Documentation Control & Record Keeping in ISO 13485
• Internal Audits & Management Review for Continuous Improvement
• Corrective & Preventive Action (CAPA) in Medical Device Manufacturing
• Training & Competence in ISO 13485 for Device Manufacturers
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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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