#softwareasamedicaldevice

Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical devices, tele-health, and digital health solutions. Most modern medical devices are manufactured with integrated software and software in general has become a deeply rooted part of medical industries the world over.

Medical software manufacturers and manufacturers of medical devices with integrated software must carefully consider the regulatory framework and new regulatory requirements to be able to put their software on the market.

While some regions have still not adopted regulations for medical device software, both the EU and the FDA have requirements for medical software and software as a medical device that rival those of traditional medical device regulations.