Certificate in Medical Device Compliance: A Practical Guide
-- ViewingNowThe Certificate in Medical Device Compliance: A Practical Guide is a comprehensive course designed to meet the growing industry demand for professionals with expertise in medical device compliance. This certificate equips learners with critical skills necessary for career advancement in this field.
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โข Regulatory framework for medical devices
โข Understanding medical device classifications
โข Quality System Requirements (QSR) and ISO 13485
โข Design Control and Risk Management principles
โข Medical Device Reporting (MDR) and Post-Market Surveillance (PMS)
โข Clinical data and labeling requirements
โข US FDA submission process and EU MDR/IVDR compliance
โข Ensuring supply chain management and traceability
โข Internal and external medical device audits and inspections
โข Corrective and Preventive Action (CAPA) system implementation
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