LONDON Wittenstein High Integrity Systems has released a SafeRTOS Design Assurance Pack which simplifies the mandatory validation process for new MCU based medical devices in the US and European Union.
The Design Assurance Pack for the SafeRTOS kernel meets US FDA510(k) Class III and European IEC EN62304 medical device certification requirements, enabling designers to cut the cost, risk and time to market for safety critical technologies.
The third-party validated kernel is available immediately to run on Cortex-M3 and ARM7 based microprocessors.
“For medical applications it is critical that third party software is not merely a retro-fitted general-purpose product, said David Brook, head of marketing at High Integrity Systems. “If it is to meet stringent regulatory standards then it must have been designed specifically to be deterministic, verifiable and certifiable.”
Risks associated with using general-purpose software and multiple support organisations are virtually eliminated with the kernel, certification and support capability delivered from a single organisation.
SafeRTOS brings the benefits of off-the-shelf software to applications with safety implications or certification requirements. SafeRTOS was first certified as developed in compliance with IEC61508 by T”V S”D in 2007.