Executive Development Programme in Orthopedic Device Regulation Compliance
-- ViewingNowThe Executive Development Programme in Orthopedic Device Regulation Compliance is a certificate course designed to equip learners with critical skills in regulatory compliance for the orthopedic device industry. This program is crucial for professionals working in or seeking to enter this sector, as it provides comprehensive training on regulatory standards, quality management, and clinical data management.
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⢠Orthopedic Device Regulations Overview
⢠Regulatory Bodies and their Roles
⢠Orthopedic Device Classification and its Importance
⢠Compliance Requirements for Orthopedic Device Manufacturing
⢠Quality System Regulation (QSR) for Orthopedic Devices
⢠Pre-market Approval (PMA) and 510(k) Submissions
⢠Labeling, Packaging, and Sterilization Requirements
⢠Post-market Surveillance and Reporting
⢠Orthopedic Device Recalls and Corrective Actions
⢠International Orthopedic Device Regulations and Compliance
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