Executive Development Programme in ISO 13485 Project Management
-- ViewingNowThe Executive Development Programme in ISO 13485 Project Management is a certificate course designed to equip learners with the essential skills needed to manage projects in the medical device industry successfully. The course focuses on ISO 13485, an international standard for medical device quality management systems, and its implementation in project management.
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โข Introduction to ISO 13485 & Project Management: Understanding the importance of implementing ISO 13485 in project management for medical devices.
โข Project Planning in ISO 13485: Identifying project requirements, setting objectives, and defining activities to meet the standard's requirements.
โข ISO 13485 Documentation Control: Managing and maintaining project documentation, including design history files, records, and change control.
โข Risk Management in ISO 13485 Projects: Implementing a risk management process throughout the project lifecycle to meet the standard's requirements.
โข Resource Management in ISO 13485 Projects: Planning, allocating, and managing resources, including personnel, equipment, and materials.
โข Quality Management & ISO 13485 Project Management: Ensuring quality throughout the project, including design, development, production, and post-market surveillance.
โข ISO 13485 Project Monitoring & Control: Implementing a process to monitor and control project progress, including measuring performance against objectives, and taking corrective action.
โข Verification & Validation in ISO 13485 Projects: Ensuring that the medical device meets the requirements and specifications, and that the project is completed successfully.
โข ISO 13485 Project Closure & Lessons Learned: Closing the project, conducting a post-project review, and capturing lessons learned for future projects.
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