Fission University

Design Lifecycle Best Practices for Medical Devices

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Design Inputs - Best Practices for Complete Product Requirements

Design inputs are the blueprints for the development of a Medical Device. This course will provide a deep understanding of how to develop user needs that will set the foundation for a successful development program and regulatory clearances.

CourseBy Jeremy Moore

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Determining User Needs - Setting the Foundation for Your Medical Device Development

An in depth primer for researching, determining, authoring, and documenting user needs for medical device development.

CourseBy Jeremy Moore

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Overview of Software as a Medical Device - Quality Systems and Regulatory Compliance

In this course, we will dive into the fascinating world of software that is designed to be used for medical purposes. Software as A Medical Device (SaMD) is becoming increasingly prevalent in modern healthcare, offering innovative solutions for diagnosis, treatment, and monitoring of various medical conditions. Throughout this course, we will explore the key concepts, regulations, and quality systems that govern the development and maintenance of SaMD. By the end of this course, you will have a comprehensive understanding of how to ensure the quality and regulatory compliance of SaMD products.

CourseBy Jeremy Moore

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