Masterclass Certificate in FDA PMA Applications
-- ViewingNowThe Masterclass Certificate in FDA PMA Applications is a comprehensive course designed to provide learners with the essential skills needed to excel in the medical device industry. This course focuses on the Pre-Market Approval (PMA) process, a crucial aspect of getting medical devices approved by the FDA.
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Here are the essential units for a Masterclass Certificate in FDA PMA (Premarket Approval) Applications:
• Understanding FDA PMA Process: An Overview
• FDA PMA Application Components
• Clinical Data Requirements for FDA PMA
• Non-Clinical Data Requirements for FDA PMA
• Labeling, Packaging, and Sterility Requirements for FDA PMA
• FDA PMA Application Review and Approval Process
• Post-Approval Requirements and Surveillance for FDA PMA
• Common PMA Application Pitfalls and How to Avoid Them
• Case Studies: Successful FDA PMA Applications
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