Medical Device Software Procedure Bundle
The Medical Device Software Procedure Bundle includes procedures related to development of software products, validation of software, software clinical evaluation, and how to apply human factors and usability engineering to the medical device development process. Also includes Medical Device Software Development Plan.
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Medical Device Software Procedure Bundle
The Medical Device Software Procedure Bundle includes procedures related to development of Software and SaMD products, validation of software, and software clinical evaluation.
Medical Device Software Procedure Bundle - Contents
The Medical Device Software Procedure Bundle includes the following procedures:Software as a Medical Device (SaMD) Development Procedure -The SaMD Development Procedure governs the planning and realization of Software as a Medical Device (SaMD) product lifecycle processes. Software Validation Procedure -The Software Validation Procedure establishes the requirements for computer systems and software used in medical device development and production, and post-distribution QA activities to ensure they have been validated for their intended use. Human Factors and Usability Engineering Procedure -The Human Factors Engineering (HFE) and Usability Engineering (UE) Procedure assists in following appropriate human factors and usability engineering processes to ensure new medical devices will be safe and effective for the intended uses and environments. Software Clinical Evaluation Procedure -The Software as a Medical Device Clinical Evaluation Procedure governs the clinical evaluation activities, including the assessment and analysis of the clinical safety, effectiveness and performance. Medical Device Software Development Plan - The Software Development Plan addresses content contained within IEC 62304:2006+A1:2015, ISO/IEC/IEEE 12207:2026 and FDA Guidance. The Medical Device Software Development Plan helps the user to organize the necessary roadmap, phases and tasks required throughout the development lifecycle, regardless of which life cycle model or approach is employed.
