Professional Certificate in Medical Device Compliance Essentials
-- ViewingNowThe Professional Certificate in Medical Device Compliance Essentials is a vital course for professionals seeking expertise in the highly regulated medical device industry. This program covers essential compliance areas, including regulatory affairs, quality assurance, and clinical affairs.
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โข Regulatory Landscape: Understanding FDA, EU MDR, and other global regulatory bodies
โข Quality Management Systems: Overview of ISO 13485 and its importance in medical device compliance
โข Design Control: Implementing design controls for medical device development
โข Risk Management: Applying ISO 14971 for risk management in medical devices
โข Clinical Evaluation: Conducting clinical evaluations and literature reviews for medical devices
โข Labeling and Packaging: Ensuring compliance with UDI, Unique Device Identification
โข Post-Market Surveillance: Monitoring and reporting adverse events and device malfunctions
โข Supply Chain Management: Ensuring compliance throughout the medical device supply chain
โข Audit and Inspection Preparedness: Preparing for FDA inspections and internal audits
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