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What we’re about

This organization is for the professionals who are the path breakers in meeting the challenges of the two worlds of regulations and quality requirements of medical devices/ healthcare and the agile development of software and hardware. The next generation medical device hardware + software, Software as Medical Device (SaMD) or Healthcare software typically also need AI and Machine Learning components. This makes the regulation more interesting and challenging. This group plans to engage with FDA to have a seat at the table for their evolving thoughts on the regulations and guidelines on developing Medical Device Software and SaMD.

The Medical Device Software, SaMD and Healthcare Software and Hardware can come in any form including but not limited to:

• Embedded

• Firmware

• Mobile Wearable

• Cloud Native

• SaaS

• Desktop



It might be using any of the technology including but not limited to:

​• Artificial Intelligence

• Machine Learning using various algorithms

• Computer Vision

• Pattern Recognition

• Image Processing

• Signal Processing

• Internet of Medical Things

• Optimization

• Heuristics