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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⢠Medical Device Regulations: Overview of global medical device regulations, including FDA, EU MDR, and MDSAP
⢠Quality Management Systems: Understanding of ISO 13485 and its implementation in medical device manufacturing
⢠Auditing Techniques: Introduction to auditing principles, methods, and tools in medical device compliance
⢠Risk Management: Application of ISO 14971 and its role in medical device compliance auditing
⢠Clinical Data Management: Collection, analysis, and reporting of clinical data for medical devices
⢠Labeling and Packaging: Compliance requirements for medical device labeling and packaging
⢠Supply Chain Management: Ensuring compliance throughout the medical device supply chain
⢠Incident Management: Reporting and investigation of medical device incidents and non-conformities
⢠Regulatory Inspections: Preparing for and managing regulatory inspections in medical device manufacturing
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