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Thought Leadership on SaMD, DTx & Connected Device Systems

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Article

Faster Feedback Through Integrated Cross-Functional Teams

agile, FDA, Human Factors & UX, medical device software development, risk management, verification & validation

This post was previously on the Pathfinder Software site. Pathfinder Software changed its name to Orthogonal in 2016. Read more. In FDA regulated software development one of the most important keys to getting the most out of agile methodology is to ensure fast feedback from outside of the development team. One way to do this […]

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Article

Crafting Good Requirements for Medical Device Software

agile, verification & validation

Good requirement documentation needs these key elements: User Stories, User Acceptance Tests, Workflows, Requirements (Details), and Wireframes.

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Bluetooth Insights

Article

Introduction to Bluetooth for Medical Devices

Webinar

Meeting FDA Requirements for BLE Mobile Medical Apps

Article

Patient Engagement & UX for Bluetooth Medical Devices

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