Insights

Orthogonals' experts share whitepapers, articles and presentations from the forefront of research in connected medical devices and companion software.  

FDA Software Precertification: A Working Guide for Medical Device Comp…

The Food & Drug Administration’s Software Precertification Program represents a fundamental paradigm shift in the regulation of medica…

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

The World Health Organization (WHO) reports that there are around 1.5 million medical devices globally, across more than 10,000 types. They …

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Orthogonal Obtains Medical ISO 13485 Certification

Orthogonal, the leader in companion software development for medical devices, today announced it has been successfully certified according t…

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The FDA Gets Serious about Digital Health

And that's a good thing.

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eBook: Agile in an FDA Regulated Environment

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

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Bluetooth and Medical Devices – Part 1: Overview

In the race to create more connected medical devices, many medical manufacturers are opting to leverage Bluetooth technology to connect to d…

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