Certificate in ISO 13485 for Engineers
-- viewing nowThe Certificate in ISO 13485 for Engineers is a comprehensive course that provides learners with the essential skills needed to design, implement, and maintain a quality management system in the medical device industry. This course highlights the importance of ISO 13485 in ensuring compliance with regulatory requirements and promoting continuous improvement in product quality and safety.
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Course Details
• Introduction to ISO 13485
• Benefits and Requirements of ISO 13485
• Understanding Quality Management Systems (QMS)
• Risk Management in Medical Devices
• Design and Development Controls in ISO 13485
• Documentation Controls and Record Keeping
• Production and Service Controls in ISO 13485
• Measurement, Analysis and Improvement
• Internal Audits and Management Review for ISO 13485
• Preparing for and Implementing 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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