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Orthogonal

FDA Software Precertification: A Working Guide for Medical Device Companies

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

19 min readJul 22, 2019

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FDA Software Precertification: A Working Guide for Medical Device Companies

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Orthogonal

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…

17 min readJun 5, 2019

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

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Orthogonal

Orthogonal Obtains ISO 13485 Certification for Medical Device Software

2 min readOct 5, 2017

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Orthogonal Obtains ISO 13485 Certification for Medical Device Software

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Orthogonal

eBook: Agile in an FDA Regulated Environment

1 min readAug 21, 2017

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Orthogonal

The FDA Gets Serious about Digital Health

5 min readAug 7, 2017

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The FDA Gets Serious about Digital Health

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Orthogonal

How to do Verification in Agile

1 min readAug 5, 2017

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Orthogonal

Join Orthogonal at Heart Rhythm 2017 in Chicago

2 min readMay 8, 2017

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Join Orthogonal at Heart Rhythm 2017 in Chicago

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Orthogonal

A Connected Health Cybersecurity Deep Dive

1 min readApr 8, 2017

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Orthogonal

Bluetooth and Medical Devices Part 1: Overview

4 min readMar 6, 2017

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Bluetooth and Medical Devices Part 1: Overview

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Orthogonal

Bluetooth and Medical Devices — Part 2: The Gotchas

5 min readMar 5, 2017

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Bluetooth and Medical Devices — Part 2: The Gotchas

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Orthogonal

Orthogonal

A software design-development firm that specializes in human factors studies, and cloud and mobile systems for the FDA regulated space.

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