Executive Development Programme in Device Software Validation
-- ViewingNowThe Executive Development Programme in Device Software Validation certificate course is a comprehensive program that emphasizes the importance of software validation in the medical device industry. With the increasing demand for regulatory compliance and product quality, this course is essential for professionals seeking to advance their careers in this field.
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โข Fundamentals of Device Software Validation: An introduction to device software validation, including its importance, regulations, and best practices. This unit will cover the basics of software validation and its role in ensuring product quality and safety.
โข Regulatory Environment and Guidelines: An overview of the regulatory environment and guidelines for device software validation, including FDA, EU, and IEC 62304. This unit will cover the applicable regulations and standards, compliance requirements, and the impact of non-compliance.
โข Software Development Life Cycle (SDLC): An in-depth look at the software development life cycle (SDLC), including the different models and their advantages and disadvantages. This unit will cover the principles of SDLC, its phases, and how it relates to device software validation.
โข Risk Management and FMEA: An exploration of risk management and Failure Modes and Effects Analysis (FMEA) in the context of device software validation. This unit will cover the principles of risk management, how to conduct FMEA, and its role in software validation.
โข Software Testing and Validation: An in-depth look at software testing and validation, including the different types of testing and their importance in device software validation. This unit will cover the principles of software testing, the different types of testing (unit, integration, system, and acceptance), and test automation.
โข Change Management and Configuration Control: An exploration of change management and configuration control in device software validation. This unit will cover the principles of change management, how to implement configuration control, and its role in ensuring software quality and safety.
โข Documentation and Record Keeping: An in-depth look at documentation and record keeping in device software validation. This unit will cover the principles of documentation, the different types of documentation (technical, user, and regulatory), and the importance of record keeping.
โข Audit and Inspection Preparation: An exploration of audit and inspection preparation in device software validation.
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