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…

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 …

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…

The FDA Gets Serious about Digital Health

And that's a good thing.

eBook: Agile in an FDA Regulated Environment

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

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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