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

bluetooth, FDA, SaMD

The move towards a highly interconnected, IoT-driven healthcare industry has made the development of mobile health applications, connected medical devices, and software as a medical device (SaMD) essential for companies looking to stay ahead of the curve. Smartphone applications, in particular, are at the forefront of the shift in how care is being delivered. With […]

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Orthogonal Obtains Medical ISO 13485 Certification

agile

Orthogonal, the leader in companion software development for medical devices, today announced it has been successfully certified according to ISO13485:2003, the international standard for medical device quality management systems. The certification bestows official recognition on the company for its agile enabled quality management system governing software product design, development, testing, enhancement and support for medical […]

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Bluetooth and Medical Devices - Part 1: Overview

bluetooth

In the race to create more connected medical devices, many medical manufacturers are opting to leverage Bluetooth technology to connect to devices with WiFi and cellular capabilities and transfer...

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Bluetooth and Medical Devices - Part 2: The Gotchas

bluetooth

Despite the shared name, BLE and Bluetooth Classic are fundamentally different connection protocols. Choosing the wrong one can have disastrous consequences for your connected medical device.

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Orthogonal at Heart Rhythm 2017 in Chicago

Join Orthogonal CEO Bernhard Kappe and other industry experts at Heart Rhythm 2017, May 10-13, 2017 at McCormick Place in Chicago, IL. Joining Kappe will be Nanowear CEO Venk Varadan and other Orthogonal clients. Industry expert presentations in Rhythm Theatres will be offered in the exhibit hall providing valuable opportunities for attendees to learn about […]

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Orthogonal New Office in San Francisco’s SoMa Neighborhood is Open

Answering strong demand for its medical device software design and development services in the Bay Area, Orthogonal LLC is opening a branch office in the Soma neighborhood in San Francisco on March 1.

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Article

Radio Frequency Wireless Technology in Medical Devices

digital health

The FDA has developed a guidance document to assist the medical device industry in appropriately addressing specific considerations related to the incorporation of radio frequency technologies.

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Article

Applying Agile in a Quality Management System

agile

Orthogonal CEO Bernhard Kappe, reviews the use of Agile development principles under a Quality Management System pursuant to FDA guidelines and regulations.

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Article

Orthogonal Congratulates Nanowear on their SimplECG™ FDA Clearance

FDA

Nanowear, a venture-backed nanotechnology startup and Orthogonal client, has successfully developed a remote diagnostic monitoring device embedded in undergarments to monitor cardiac activity.

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Article

SaMD: Software as a Medical Device

SaMD

The U.S. Food and Drug Administration has issued a guidance document entitled "Software as a Medical Device (SaMD): Clinical Evaluation.

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Article

Orthogonal™ Announces New Brand and Pivots to IoT Medical Device Software

medical device software development

In light of market changes in health care and the ascension of IoT medical devices, Orthogonal has decided to concentrate its expertise solely in the connected medical device space.

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