Global Certificate Course in Biomedical Device Regulation
-- ViewingNowBiomedical Device Regulation: Gain a global perspective on medical device regulations. This certificate course is ideal for medical device professionals, regulatory affairs specialists, and quality engineers.
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2个月完成
每周2-3小时
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课程详情
- Introduction to Global Medical Device Regulations
- US FDA Regulations (21 CFR Part 820)
- EU Medical Device Regulation (MDR) 2017/745
- ISO 13485:2016 Quality Management Systems
- Global Harmonization and Regulatory Strategies
- Risk Management and Clinical Evaluation
- Post-Market Surveillance and Vigilance
- Regulatory Affairs and Compliance
- Design Controls and Verification & Validation
职业道路
Career Role Description Regulatory Affairs Specialist (Biomedical Devices) Ensuring compliance with UK and EU medical device regulations (MDR, IVDR).
High demand for expertise in biomedical device classification and regulatory submissions.
Quality Assurance Engineer (Medical Devices) Maintaining quality systems and processes throughout the entire lifecycle of biomedical devices, guaranteeing compliance with regulations and standards.
Essential for biomedical device quality and safety.
Clinical Engineer (Biomedical Devices) Applying engineering principles to clinical settings, including maintenance, troubleshooting, and selection of biomedical equipment.
Strong knowledge of biomedical device technology is critical.
Biomedical Device Consultant Providing expert advice on regulatory compliance, risk management, and product development within the biomedical device sector.
A high-level role requiring deep biomedical device knowledge.
入学要求
- 对主题的基本理解
- 英语语言能力
- 计算机和互联网访问
- 基本计算机技能
- 完成课程的奉献精神
无需事先的正式资格。课程设计注重可访问性。
课程状态
本课程为职业发展提供实用的知识和技能。它是：
- 未经认可机构认证
- 未经授权机构监管
- 对正式资格的补充
成功完成课程后，您将获得结业证书。
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