Experts in embedded RTOS, with a specialisation in safety certified software
SAFERTOS provides developers with a responsive, robust, deterministic, embedded Real Time Operating System (RTOS). It contains features needed for the development of medical devices, and the Design History File provides all the documentation required for an easy route to achieving certification of SAFERTOS once integrated within a medical device.
By specifically supporting the needs of medical device developers, SAFERTOS can greatly reduce program risks, lower development costs and shorten the time to market for medical device products.
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Common Medical Devices Using SafeRTOS
Case Study: Ottobock
Ottobock chose SAFERTOS to replace all of their custom embedded software across their microprocessor controlled lower limb prostheses. They have this to say about WITTENSTEIN high integrity systems:
SAFERTOS supports FDA 510(k) class III device submissions and IEC 62304 class C certifications.
The SAFERTOS Safety Manual clearly details how to install and integrate SAFERTOS into a medical device development environment. Following the concise instructions contained within the Safety Manual preserves the verification and validation already performed, and removes the need for expensive and prolonged retesting on the target hardware.
- Matthias Hölzer-Klüpfel, Independent Consultant & Co-Founder of International Certified Professional for Medical Software Board e.V.
The SAFERTOS Design History File complies with the requirements of 21 CFR 820. The Design History File contains the documentation and testing evidence, which supports SAFERTOS inclusion in a Major Level Of Concern submission, according to the guidelines contained in the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The Design History File contains every planning, design and verification document generated during the development of the SAFERTOS variant for a specific processor/compiler combination. The Design History File Contents are:
Case Study: The world’s first ‘Warmed Liver’ transplant was carried out successfully, using technology devised by OrganOx with SAFERTOS at its core.
The SAFERTOS high integrity design life cycle implements a risk management system that, where applicable, complies with ISO 14971:2009 “Application of risk management to medical devices”.
This provides reassurance that SAFERTOS has been designed to meet the safety requirements for use within a medical device. It also allows for the easy integration of the Design History File into a medical device development environment.
The Task Isolation and Separation feature of SAFERTOS enables medical device developers to co-locate safety critical code with non-safety critical code.
For example, this means that a critical Infusion Pump control algorithm and graphical interface code can be within the same linear memory space.
SAFERTOS achieves this by using either the Memory Management Unit (MMU) or the Memory Protection Unit (MPU). Used effectively this can greatly reduce the amount of safety critical code required within a medical device.
SAFERTOS enables dual and multicore/processor medical device designers to create seamless, mixed safety criticality designs quickly and efficiently. Due to its small size and its safety critical credentials, SAFERTOS is ideally suited for use on the primary core. This allows the system to boot and configure itself securely before enabling other cores that could run non-critical applications such as Linux to implement web servers and WiFi connections.
In a multicore environment, SAFERTOS is typically used on cores implementing safety critical functionality, or on cores providing monitoring/verification of the primary function. Due to its high safety classification, SAFERTOS can safely be used on both primary and monitoring cores, removing the need to use differential software.
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