White Papers

Thought Leadership on SaMD, DTx & Connected Device Systems

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White Paper

White Paper: Smartphone Market Analysis for Software as a Medical Device Developers

bluetooth, SaMD

Introduction Since the introduction of the iPhone in 2007, iOS and Android smartphones have come to define and dominate the U.S. smartphone market, with approximately 81% of American adults owning a smartphone by 2019 and over 99% of those smartphones being either an iOS or Android phone. As the following graph illustrates, since the iPhone […]

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White Paper

Software as a Medical Device (SaMD): What It Is & Why It Matters

SaMD

The World Health Organization (WHO) reports that there are around 1.5 million medical devices globally, across more than 10,000 types. They range from simple medical equipment like stethoscopes to highly complex, expensive devices like MRI machines. Over the last 40 years, the amount of software used both in and around medical devices has dramatically increased. […]

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White Paper

AI and the Design of Medical Devices: It's Getting Better All The Time

AI & machine learning, digital health, SaMD

Orthogonal was excited that Bernhard Kappe, our CEO and Founder, spoke at Virtual Engineering Week on Friday, December 4th, 2020 on the topic of AI & Machine Learning in Medical Devices: It’s Getting Better All the Time. This talk was hosted by Informa and their Medical Device + Diagnostic Industry (MD+DI) media property. (Shout outs […]

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White Paper

Agile in an FDA Regulated Environment

agile, FDA

How do you get the benefits of agile while maintaining quality and regulatory compliance?

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White Paper

White Paper: Smartphone Market Analysis for Software as a Medical Device

bluetooth, FDA, SaMD
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