Advanced Skill Certificate in Biomedical Device Risk Management
-- viewing nowBiomedical Device Risk Management: This advanced certificate equips professionals with in-depth knowledge of risk assessment, mitigation, and regulatory compliance. Designed for medical device professionals, engineers, and quality managers, the program covers ISO 14971, risk analysis methods like FMEA and FTA, and regulatory requirements for risk management.
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Course details
• Risk Management Tools and Techniques (FMEA, FTA, etc.)
• Regulatory Requirements for Biomedical Devices (FDA, MDR, etc.)
• Post-Market Surveillance and Vigilance
• Usability Engineering and Human Factors
• Risk Communication and Management Reviews
• Case Studies in Biomedical Device Risk Management
• Software Risk Management in Medical Devices
Career path
Advanced Skill Certificate in Biomedical Device Risk Management: UK Job Market Outlook
Career Role (Biomedical Device Risk Management) | Description |
---|---|
Senior Biomedical Engineer (Risk Management) | Lead risk assessments, manage regulatory compliance, and oversee device safety throughout the product lifecycle. |
Regulatory Affairs Specialist (Medical Devices) | Ensure compliance with regulatory requirements (e.g., ISO 14971, MDR) for biomedical devices. Expert in risk management documentation. |
Quality Assurance Manager (Biomedical Devices) | Oversee quality systems, including risk management processes, to ensure device safety and effectiveness. |
Risk Management Consultant (Medical Devices) | Provide expert advice on risk management strategies and regulatory compliance to biomedical device companies. |
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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