Professional Certificate in ISO 13485 for Healthcare
-- viewing nowThe Professional Certificate in ISO 13485 for Healthcare is a comprehensive course designed to equip learners with the necessary skills to implement and maintain a quality management system in the medical device industry. This certification is essential for professionals seeking to advance their careers in healthcare, as it demonstrates a deep understanding of ISO 13485, a crucial standard for the design, production, installation, and servicing of medical devices.
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Course Details
Here are the essential units for a Professional Certificate in ISO 13485 for Healthcare:
- • ISO 13485:2016 Overview
- • Quality Management System (QMS) Requirements
- • Medical Device Life Cycle and Risk Management
- • Documentation and Record Keeping
- • Management Review and Internal Audits
- • Corrective and Preventive Action (CAPA) Process
- • Training and Competence Requirements
- • Validation, Verification, and Monitoring
- • Supplier Management and Control
- • Continuous Improvement in Healthcare Quality
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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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