Insights

When Should Your Connected Medical Device Support Bluetooth 5.0?

With over eight in 10 adults now owning a smart device, the “internet of everything” (IoE) has become more accessible to both patients a…

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 …

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.