Global Certificate in Smart Medical Device Regulatory Systems
-- ViewingNowThe Global Certificate in Smart Medical Device Regulatory Systems is a comprehensive course designed to meet the growing industry demand for experts in this field. This certificate program emphasizes the importance of understanding global regulations for smart medical devices, a critical aspect of ensuring patient safety and driving innovation.
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⢠Global Regulatory Landscape: Understanding the international regulatory framework for smart medical devices, including FDA, EU MDR, and other regional requirements.
⢠Device Classification: Identifying and classifying smart medical devices according to global regulatory standards.
⢠Quality Management Systems: Designing and implementing a Quality Management System (QMS) for smart medical devices, in compliance with ISO 13485 and other relevant standards.
⢠Clinical Evaluation and Data Management: Conducting clinical evaluations and managing clinical data to demonstrate the safety and effectiveness of smart medical devices.
⢠Risk Management: Applying risk management principles to smart medical devices, in accordance with ISO 14971 and other relevant standards.
⢠Labeling and Packaging: Creating compliant labeling and packaging for smart medical devices, in line with global regulatory requirements.
⢠Post-Market Surveillance: Establishing and maintaining post-market surveillance systems to monitor the performance and safety of smart medical devices.
⢠Regulatory Submissions: Preparing and submitting regulatory applications for smart medical devices to global authorities, such as the FDA and EU Notified Bodies.
⢠Regulatory Compliance Maintenance: Ensuring ongoing compliance with global regulatory requirements, including the management of changes, updates, and renewals.
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