Executive Development Programme in Device Safety Assessment
-- ViewingNowThe Executive Development Programme in Device Safety Assessment is a certificate course designed to equip learners with essential skills in the field of device safety assessment. This program emphasizes the importance of ensuring device safety in various industries, including healthcare, automotive, and consumer electronics.
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โข Device Safety Assessment Fundamentals: Understanding the basic principles and concepts of device safety assessment, including risk identification, evaluation, and mitigation.
โข Regulatory Compliance: Overview of global regulations and standards for device safety, such as FDA, EU MDR, IEC 60601, and UL 2601-1.
โข Hazard Analysis and Risk Management: Techniques for conducting hazard analysis, risk assessment, and risk management to ensure device safety.
โข Safety Testing Methodologies: Introduction to various safety testing methodologies, such as electrical safety, software safety, and environmental safety testing.
โข Human Factors Engineering: Understanding the role of human factors engineering in device safety assessment and how to incorporate human factors in the design process.
โข Performance Testing and Validation: Techniques for testing and validating device performance, including software validation and verification (V&V) and performance testing.
โข Quality Management Systems: Overview of quality management systems, such as ISO 13485, and their role in ensuring device safety.
โข Supply Chain Management: Understanding the importance of supply chain management in device safety assessment and strategies for managing suppliers and vendors.
โข Incident Analysis and Reporting: Techniques for analyzing device incidents, reporting adverse events, and implementing corrective actions.
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