Masterclass Certificate in Advanced ISO 13485
-- viewing nowThe Masterclass Certificate in Advanced ISO 13485 is a comprehensive course designed for professionals seeking expertise in the medical device industry's quality management systems. This certification focuses on the latest ISO 13485:2016 standards, emphasizing risk-based approaches and up-to-date regulatory requirements.
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Course Details
• Introduction to ISO 13485 & Medical Device Quality Management Systems
• Understanding ISO 13485 Requirements &
• Risk Management in ISO 13485
• Documentation Control &
• Design and Development Controls
• Production, Sterilization, &
• Purchasing &
• Measurement, Analysis, & Improvement
• Internal Audit &
• Preparing for 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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