Advanced Certificate in Medical Textile Regulatory Compliance
-- ViewingNowThe Advanced Certificate in Medical Textile Regulatory Compliance is a comprehensive course designed to meet the growing industry demand for experts knowledgeable in medical textile regulations. This certificate program emphasizes the importance of understanding and navigating complex regulatory frameworks to ensure product safety and compliance, particularly in the medical textile sector.
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โข Medical Textile Fundamentals: Understanding the properties and uses of medical textiles, including their role in healthcare and regulatory compliance.
โข Regulatory Bodies and Guidelines: Overview of regulatory agencies and their guidelines, such as FDA, EU MDR, and ISO 13485.
โข Risk Management in Medical Textiles: Implementing and maintaining risk management processes in accordance with ISO 14971.
โข Clinical Evaluation and Testing: Methods and best practices for clinical evaluation and testing of medical textiles.
โข Medical Textile Labeling and Packaging: Ensuring compliance with labeling and packaging regulations, including UDI and GS1 standards.
โข Quality Management Systems: Designing, implementing, and maintaining a robust quality management system (QMS) in compliance with ISO 13485.
โข Supply Chain Management and Traceability: Ensuring end-to-end supply chain visibility and compliance with regulations.
โข Change Management and Post-Market Surveillance: Managing changes to medical textile products, as well as post-market surveillance and vigilance.
โข Audit and Inspection Preparation: Preparing for and managing audits and inspections from regulatory bodies.
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