Global Certificate in Medical Device Compliance Auditing
-- ViewingNowThe Global Certificate in Medical Device Compliance Auditing is a comprehensive course designed to meet the growing industry demand for experts knowledgeable in medical device regulations and compliance. This course equips learners with crucial skills necessary for auditing medical devices, ensuring compliance with international standards, and managing regulatory affairs.
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โข Medical Device Regulations: Overview of global medical device regulations, including FDA, EU MDR, and MDSAP
โข Quality Management Systems: Understanding of ISO 13485 and its implementation in medical device manufacturing
โข Auditing Techniques: Introduction to auditing principles, methods, and tools in medical device compliance
โข Risk Management: Application of ISO 14971 and its role in medical device compliance auditing
โข Clinical Data Management: Collection, analysis, and reporting of clinical data for medical devices
โข Labeling and Packaging: Compliance requirements for medical device labeling and packaging
โข Supply Chain Management: Ensuring compliance throughout the medical device supply chain
โข Incident Management: Reporting and investigation of medical device incidents and non-conformities
โข Regulatory Inspections: Preparing for and managing regulatory inspections in medical device manufacturing
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