Global Certificate in ISO 13485 and MDR Compliance
-- ViewingNowThe Global Certificate in ISO 13485 and MDR Compliance course is a comprehensive program that equips learners with the necessary skills to excel in the medical device industry. This course emphasizes the importance of understanding and implementing ISO 13485, a quality management system standard specific to the medical device industry, and the European Medical Device Regulation (MDR).
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โข Introduction to ISO 13485: Understanding the standard, its purpose, and benefits for medical device organizations
โข Key Components of ISO 13485: Quality management system, documentation, management responsibility, resource management, product realization, and measurement, analysis, and improvement
โข ISO 13485 vs ISO 9001: Comparing the requirements and differences for medical device organizations and general manufacturing
โข Implementing ISO 13485: Steps, tools, and best practices for a successful implementation
โข Internal Audit and Management Review: Preparing and conducting internal audits, and management review processes for continuous improvement
โข MDR (Medical Device Regulation) Overview: Understanding the new regulation and its impact on medical device organizations
โข MDR Compliance and Risk Management: Implementing risk management processes for MDR compliance
โข MDR Labeling and Technical Documentation: Requirements and best practices for labeling and technical documentation
โข MDR Vigilance and Post-Market Surveillance: Processes for post-market surveillance and vigilance for MDR compliance
โข MDR and ISO 13485 Integration: Strategies for integrating MDR requirements into an existing ISO 13485 quality management system.
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