Global Certificate in MedTech Product Compliance
-- ViewingNowThe Global Certificate in MedTech Product Compliance course is a comprehensive program designed to meet the growing demand for experts in the medical technology industry. This course highlights the importance of regulatory compliance in product development, manufacturing, and post-market surveillance.
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โข Regulatory Frameworks in MedTech Product Compliance: Understanding the global regulatory landscape, including FDA, EU MDR, and other regional requirements.
โข Quality Management Systems (QMS): Implementing and maintaining a robust QMS to meet MedTech product compliance standards.
โข Risk Management in MedTech: Identifying, assessing, and mitigating risks associated with MedTech products, in line with ISO 14971.
โข Design Control and Documentation: Managing design processes and documentation for MedTech products, adhering to regulatory requirements.
โข Clinical Evaluation and Investigations: Conducting clinical evaluations and investigations to ensure product safety and efficacy.
โข MedTech Labeling and Packaging: Compliance with regulatory labeling and packaging requirements, including UDI and IFU.
โข Post-Market Surveillance (PMS): Implementing and managing PMS programs to monitor product performance and comply with regulatory requirements.
โข MedTech Product Recalls and Adverse Events: Managing MedTech product recalls and adverse events, in accordance with regulatory guidelines.
โข Supply Chain Management and Distribution: Ensuring compliance in supply chain management and distribution processes.
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