Advanced Certificate in ISO 13485 for a Changing World
-- viewing nowThe Advanced Certificate in ISO 13485 for a Changing World is a comprehensive course designed to equip learners with the essential skills needed to excel in the ever-evolving medical device industry. This certificate program focuses on the latest updates and revisions to ISO 13485, the international quality management system standard for medical devices, and emphasizes the critical role of risk management and change control in today's rapidly changing landscape.
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Course Details
• Introduction to ISO 13485:2016 & Changing Regulatory Landscape
• Understanding Medical Device Quality Management System (QMS)
• Risk Management in ISO 13485:2016
• Design and Development of Medical Devices
• Documentation and Record Keeping in ISO 13485:2016
• Implementing and Maintaining ISO 13485:2016 QMS
• Internal Audits and Management Review
• Preparing for ISO 13485:2016 Certification
• Continuous Improvement in a Changing World
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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