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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โข Orthopedic Device Regulations Overview
โข Regulatory Bodies and their Roles
โข Orthopedic Device Classification and its Importance
โข Compliance Requirements for Orthopedic Device Manufacturing
โข Quality System Regulation (QSR) for Orthopedic Devices
โข Pre-market Approval (PMA) and 510(k) Submissions
โข Labeling, Packaging, and Sterilization Requirements
โข Post-market Surveillance and Reporting
โข Orthopedic Device Recalls and Corrective Actions
โข International Orthopedic Device Regulations and Compliance
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