Global Certificate in Medical Devices
-- ViewingNowThe Global Certificate in Medical Devices course is a comprehensive program designed to meet the growing industry demand for experts in medical devices. This course emphasizes the importance of medical devices in modern healthcare, focusing on the critical skills needed to develop, market, and regulate these life-saving technologies.
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โข Medical Devices Fundamentals: Overview of medical devices, classification, and regulatory frameworks
โข Medical Device Design and Development: Principles of design controls, design inputs and outputs, and design validation
โข Risk Management in Medical Devices: Implementing ISO 14971, risk identification, assessment, and control
โข Clinical Evaluation and Post-Market Surveillance: Understanding clinical data, performance studies, and post-market vigilance
โข Medical Device Quality Management Systems: Implementing ISO 13485 and ensuring compliance
โข Labeling, Instructions for Use, and Traceability: Compliance with regulations, labeling best practices, and traceability systems
โข Medical Device Regulatory Affairs: Global regulatory frameworks, submissions, and approvals
โข Sterilization and Packaging of Medical Devices: Sterilization methods, packaging requirements, and validation
โข Medical Device Software and Cybersecurity: Software lifecycle management, IEC 62304, and cybersecurity considerations
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