Professional Certificate in Regulatory Affairs for IVD Compliance Documentation
-- ViewingNowThe Professional Certificate in Regulatory Affairs for IVD Compliance Documentation is a crucial course for professionals seeking expertise in regulatory affairs for in vitro diagnostic (IVD) devices. This program addresses the increasing demand for specialists who can navigate complex regulatory landscapes and ensure compliance with IVD directives.
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⢠Regulatory Foundations for IVD Compliance: Understanding global regulatory frameworks, including IVD directives and regulations, FDA regulations, and international standards (ISO 13485, ISO 14971).
⢠Quality Management Systems (QMS): Implementing and maintaining a compliant QMS for IVD device design, development, and production. Risk management, document control, and CAPA processes.
⢠Clinical Evidence and Performance Evaluation: Designing, conducting, and reporting clinical studies to support IVD device performance claims. Performance evaluation plans and post-market surveillance.
⢠Labeling, Instructions for Use (IFU), and Promotional Materials: Creating and reviewing labeling and promotional materials for IVD devices, ensuring compliance with regulations and standards.
⢠Regulatory Submissions and Approvals: Preparing and submitting regulatory applications for IVD devices, including 510(k) premarket notifications, PMAs, and CE marking applications.
⢠Regulatory Compliance Audits: Conducting internal and external audits to assess compliance with regulatory requirements and identify areas for improvement. Responding to regulatory inspections and managing corrective actions.
⢠Post-Market Surveillance and Vigilance: Monitoring and reporting adverse events, implementing corrective actions, and ensuring ongoing compliance with post-market requirements.
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