Global Certificate in FDA MDR Investigations
-- ViewingNowThe Global Certificate in FDA MDR Investigations is a comprehensive course designed to meet the growing industry demand for professionals skilled in FDA Medical Device Reporting (MDR). This certification equips learners with critical skills required to navigate the complex MDR landscape, ensuring compliance with FDA regulations and fostering a culture of patient safety.
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⢠FDA Medical Device Reporting (MDR) Regulations
⢠Understanding MDR Requirements and Compliance
⢠Data Elements and Formatting for MDR Submissions
⢠Adverse Event Analysis and Reporting for FDA MDR
⢠MDR Recordkeeping and Retention
⢠FDA Inspection Preparation for MDR Investigations
⢠MDR Investigation Response and Corrective Action
⢠Quality System Requirements for MDR
⢠Case Study: Real-World MDR Investigation Scenarios
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