Global Certificate Course in Biomedical Engineering for Medical Device Regulation
-- viewing nowBiomedical Engineering professionals face complex medical device regulations globally. This Global Certificate Course provides in-depth knowledge of international standards like ISO 13485 and FDA regulations.
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Course details
• GMP (Good Manufacturing Practices) for Medical Devices
• Risk Management & ISO 14971
• Design Controls & Design Verification & Validation
• Clinical Evaluation & Post-Market Surveillance
• Regulatory Affairs & Submission Strategies
• Quality System Regulation (QSR) & ISO 13485
• International Medical Device Regulations (e.g., FDA, EU MDR)
• Cybersecurity in Medical Devices
• Intellectual Property & Regulatory Compliance
Career path
Career Role (Biomedical Engineering & Medical Device Regulation) | Description |
---|---|
Regulatory Affairs Specialist (Medical Devices) | Ensures compliance with UK and EU medical device regulations (MDR, IVDR). Manages product registrations and lifecycle management. High demand. |
Biomedical Engineer (Regulatory Focus) | Applies engineering principles to ensure medical device safety and regulatory compliance. Strong technical and regulatory knowledge is crucial. |
Quality Assurance Engineer (Medical Devices) | Oversees quality management systems for medical devices, ensuring compliance with relevant regulations (ISO 13485). Essential role in device development. |
Clinical Engineering Specialist | Maintains and manages medical equipment in healthcare settings, ensuring safe and effective operation. Growing demand in the UK healthcare system. |
Medical Device Consultant (Regulatory) | Provides expert advice on medical device regulations and compliance strategies. High-level understanding of regulatory frameworks is vital. |
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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