Executive Development Programme in Device Compliance Essentials
-- ViewingNowThe Executive Development Programme in Device Compliance Essentials certificate course is a comprehensive program designed to provide learners with critical knowledge and skills in device compliance. This course is essential in today's rapidly evolving industry, where compliance is paramount to ensure the safety, effectiveness, and quality of medical devices.
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โข Device Compliance Fundamentals: Understanding regulations, guidelines, and compliance requirements for medical devices. โข Risk Management: Identifying, assessing, and mitigating risks in medical devices in accordance with ISO 14971. โข Quality Management System: Implementing and maintaining a QMS based on ISO 13485, including document control, CAPA, and management review. โข Design Control & Verification: Applying design control principles and verifying medical devices to meet user needs and intended use. โข Clinical Evaluation & Validation: Conducting clinical evaluations and validations to demonstrate safety and performance. โข Labeling & Instructions for Use: Designing and implementing compliant labeling and IFU to meet regulatory requirements. โข Supply Chain Management: Managing suppliers and ensuring compliance throughout the supply chain. โข Post-Market Surveillance & Vigilance: Monitoring and reporting adverse events and implementing corrective actions as needed. โข Regulatory Affairs & Submissions: Navigating the regulatory landscape, preparing and submitting regulatory applications.
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