Advanced Certificate in Biomedical Device Software Quality
-- viewing nowThe Advanced Certificate in Biomedical Device Software Quality course is a vital program for professionals seeking expertise in the highly regulated medical device industry. This course emphasizes the importance of software quality assurance and compliance with industry standards such as ISO 13485 and FDA regulations.
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Course Details
• Software Development Life Cycle (SDLC) in Biomedical Device Industry
• Quality System Regulation and ISO 13485:2016 for Biomedical Device Software
• Risk Management in Biomedical Device Software Development (ISO 14971)
• Software Validation and Verification for Biomedical Devices
• Design Controls and Documentation for Biomedical Device Software
• Human Factors and Usability Engineering in Biomedical Device Software
• Change Management and Configuration Control for Biomedical Device Software
• Software Maintenance, Support, and Problem Resolution
• Regulatory Affairs and Compliance for Biomedical Device Software
• Biomedical Device Software Security and Data Privacy (e.g., HIPAA, GDPR)
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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