Linux in Medical Devices

By Ken Herold

Ken HeroldLinux is the operating system of choice for a wide range of medical devices, from vital sign monitors to hospital bedside “infotainment” systems to complex imaging and scanning equipment. Yet not all Linux is alike. Because patients’ lives may be in the balance, software used in medical devices must meet stringent regulatory guidelines to assure that it will perform as promised, and the provider must be able to pass audits of its development methodologies. Trying to cobble together solutions from pure Linux without commercial support puts the burdens of testing, validation, documentation and compliance on the device manufacturers and their developers – an onerous, time consuming and complex process that can turn “free” Linux into a very costly proposition.

There are, of course, commercial vendors of Linux who provide value-added, stabilized versions of the open source software, along with board support packages. Service, support and documentation levels, however, vary widely among them.  Some chip vendors provide software solely to drive processor sales and with many vendors, the relationship ends with the sale.

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