Professional Certificate in Medical Device Regulatory Affairs Best Practices
-- ViewingNowThe Professional Certificate in Medical Device Regulatory Affairs Best Practices course is a comprehensive program designed to equip learners with the essential skills needed to thrive in the medical device industry. This course highlights the importance of regulatory affairs by teaching best practices, industry standards, and compliance requirements.
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โข Medical Device Regulations Overview
โข Global Regulatory Landscape for Medical Devices
โข Quality Management Systems in Medical Device Regulatory Affairs
โข Regulatory Strategy and Product Lifecycle Management
โข Clinical Data and Regulatory Submissions
โข Medical Device Classification and Risk Management
โข Labeling, Packaging, and Sterilization Requirements
โข Post-Market Surveillance, Vigilance, and Complaint Handling
โข International Medical Device Regulations (e.g., EU MDR, MDSAP, FDA)
โข Regulatory Affairs Best Practices and Compliance
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