Insights

When Should Your Connected Medical Device Support Bluetooth 5.0?

Bluetooth 5.0 introduced many specification upgrades to the previous versions of Bluetooth. Some of the most important upgrades include 8x t…

Whitepaper: Smartphone Market Analysis for Connected Medical Devices &…

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 …

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?

Orthogonal On Mobile Apps for Medical Devices at the American Medical …

Orthogonal will be at the American Medical Device (AMD) Summit from October 28-29, 2019. Located at the Hyatt Regency O’Hare Hotel in Chic…

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…