Global Certificate in Device Regulations
-- ViewingNowThe Global Certificate in Device Regulations course is a comprehensive program designed to provide learners with a deep understanding of the complex regulatory landscape governing medical devices. This course is crucial in an industry where compliance is paramount, and it covers regulations in various global markets, including the US, Europe, and Asia.
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โข Global Device Regulations Overview: An introduction to global device regulations, including primary and secondary keywords. โข Medical Device Classification: Explanation of medical device classification systems used in different regions. โข Regulatory Pathways for Medical Devices: Discussion of the various regulatory pathways for medical devices in different countries. โข Labeling and Packaging Requirements: Overview of labeling and packaging requirements for medical devices in different regions. โข Clinical Data and Evaluation: Explanation of clinical data and evaluation requirements for medical devices in different regions. โข Quality Management Systems: Overview of quality management systems and their importance in medical device regulations. โข Post-Market Surveillance and Vigilance: Explanation of post-market surveillance and vigilance requirements for medical devices in different regions. โข Regulatory Compliance and Audits: Overview of regulatory compliance and audit requirements for medical devices in different regions.
โข Global Harmonization and Collaboration: Discussion of global harmonization and collaboration efforts in medical device regulations.
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