Professional Certificate in Device Documentation Requirements
-- ViewingNowThe Professional Certificate in Device Documentation Requirements is a comprehensive course designed to meet the growing industry demand for experts who can manage device documentation. This course emphasizes the importance of accurate and up-to-date device documentation, which is essential for regulatory compliance, product quality, and patient safety.
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โข Device Documentation Overview: Understanding the importance, types, and best practices of device documentation.
โข Regulatory Requirements: Compliance with FDA, EU MDR, and other global regulations for medical device documentation.
โข Design Inputs and Outputs: Documenting design controls, inputs, and outputs during the product development process.
โข Risk Management: Implementing ISO 14971 and applying risk management principles in device documentation.
โข Technical Files and Design Dossiers: Compiling and maintaining comprehensive technical files and design dossiers.
โข Labeling and Packaging: Documenting labeling and packaging requirements, including UDI and IFU.
โข Clinical Evaluation Reports: Preparing and updating clinical evaluation reports according to MEDDEV 2.7/1 rev. 4.
โข Change Management: Managing changes and revisions in device documentation, ensuring traceability.
โข Document Control and Storage: Establishing and maintaining document control processes and storage systems.
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