Advanced Certificate in Practical ISO 13485 Application
-- ViewingNowThe Advanced Certificate in Practical ISO 13485 Application is a comprehensive course that provides learners with essential skills for career advancement in the medical device industry. This certificate course focuses on the application of ISO 13485, the international standard for medical device quality management systems, and its importance in ensuring compliance with regulatory requirements.
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โข Introduction to ISO 13485: Understanding the Standard & Its Importance
โข Risk Management in Medical Device Quality Management Systems
โข Documentation Requirements for ISO 13485 Compliance
โข Design and Development Control for Medical Devices
โข Production, Sterilization, and Monitoring Processes
โข Management Review and Internal Audits for Continuous Improvement
โข Providing Training & Competence for ISO 13485 Personnel
โข Measurement, Analysis, and Improvement of the QMS
โข Implementing Corrective and Preventive Action Strategies
โข Case Studies: Real-World ISO 13485 Application in Medical Organizations
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