Masterclass Certificate in Regulatory Compliance for Medical Printing
-- ViewingNowThe Masterclass Certificate in Regulatory Compliance for Medical Printing is a comprehensive course designed to meet the growing industry demand for experts with a deep understanding of medical printing regulations. This course equips learners with critical skills necessary for career advancement in this field.
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⢠Regulatory Framework for Medical Printing: Understanding FDA regulations, EU medical device directives, and other international standards for medical printing
⢠Medical Device Classification: Classifying medical devices and understanding the impact on regulatory requirements
⢠Design Controls for Medical Printing: Implementing design controls, including design inputs, outputs, and verification/validation activities
⢠Risk Management in Medical Printing: Applying ISO 14971 and other risk management standards to medical printing
⢠Labeling and Packaging Requirements: Meeting UDI, Unique Device Identification, and other labeling and packaging requirements
⢠Quality Management System for Medical Printing: Implementing a QMS, including document control, corrective and preventive action, and supplier management
⢠Clinical Evaluation and Testing: Conducting clinical evaluations and testing to demonstrate safety and effectiveness
⢠Post-Market Surveillance and Vigilance: Implementing post-market surveillance and vigilance programs to monitor and report adverse events
⢠Regulatory Submissions for Medical Printing: Preparing and submitting regulatory applications, including 510(k) premarket notifications, PMA premarket approvals, and EU Technical Files
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