Certificate in Medical Device Compliance Assessment
-- ViewingNowThe Certificate in Medical Device Compliance Assessment is a comprehensive course designed to equip learners with the essential skills required for career advancement in the medical device industry. This course emphasizes the importance of regulatory compliance, quality management, and risk assessment in medical device development and manufacturing.
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Medical Device Regulations and Standards
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ISO 13485: Quality Management System for Medical Devices
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Medical Device Risk Management (ISO 14971)
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Design Control for Medical Devices (FDA and ISO requirements)
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Medical Device Labeling and Packaging
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Medical Device Clinical Trials and Data Requirements
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Post-Market Surveillance and Vigilance
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Medical Device Compliance Audits and Inspections
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Regulatory Affairs for Medical Device Submissions and Approvals
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Supply Chain Management and Distribution of Medical Devices
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