Undergraduate Certificate in Quality Assurance of Medical Devices
-- ViewingNowThe Undergraduate Certificate in Quality Assurance of Medical Devices is a comprehensive course that equips learners with critical skills necessary for ensuring the highest standards in medical device production. This program emphasizes the importance of quality assurance and regulatory compliance, making it highly relevant in an industry where precision and safety are paramount.
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โข Introduction to Quality Assurance in Medical Devices: Fundamentals of quality assurance, regulations, and standards in medical devices
โข Medical Device Design Control: Design and development process, design inputs, outputs, and verification
โข Risk Management in Medical Devices: ISO 14971, risk identification, assessment, and control
โข Quality Systems for Medical Devices: ISO 13485, quality management system requirements
โข Medical Device Production and Process Control: Production processes, control methods, and documentation
โข Medical Device Inspection and Testing: Inspection and testing methods, acceptance criteria, and statistical techniques
โข Medical Device Product Verification and Validation: Validation principles, protocols, and reporting
โข Complaint Handling and Medical Device Vigilance: Adverse event reporting, complaint handling, and vigilance systems
โข Medical Device Quality Assurance Case Studies: Real-world examples and best practices
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