Professional Certificate in Medical Device Manufacturing Processes
-- ViewingNowThe Professional Certificate in Medical Device Manufacturing Processes is a comprehensive course designed to equip learners with the essential skills required in the medical device industry. This program highlights the importance of understanding manufacturing processes, ensuring regulatory compliance, and maintaining product quality.
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⢠Medical Device Manufacturing Regulations: An overview of regulations and standards in medical device manufacturing, including FDA regulations, ISO 13485, and Quality System (QS) regulation.
⢠Design Control for Medical Devices: Understanding the design control process, including requirements, design inputs, outputs, and verification/validation activities.
⢠Materials and Sterilization in Medical Device Manufacturing: An overview of materials used in medical device manufacturing, sterilization methods, and their impact on product quality and safety.
⢠Manufacturing Processes and Equipment: An overview of medical device manufacturing processes, including injection molding, machining, and assembly, and equipment used in these processes.
⢠Risk Management in Medical Device Manufacturing: Understanding risk management principles and their application in medical device manufacturing, including failure modes and effects analysis (FMEA) and hazard analysis.
⢠Quality Assurance and Control in Medical Device Manufacturing: An overview of quality assurance and control principles, including statistical process control (SPC), and their application in medical device manufacturing.
⢠Supply Chain Management for Medical Devices: Understanding supply chain management principles and their application in medical device manufacturing, including vendor selection, inventory management, and logistics.
⢠Medical Device Validation and Verification: An overview of medical device validation and verification, including design validation, process validation, and performance testing.
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