SAFERTOS For Medical Devices
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.
WITTENSTEIN high integrity systems attend many medical shows and conferences. Find out which ones we’re attending here.
Common Medical Devices Using SafeRTOS
- Infusion pumps
- Dialysis machines
- Insulin pumps
- Hemostasis analyzer system
- Liver perfusion machines
- Ventricular Assist Devices
- Cardio-vascular/hypertension monitors
- Self-monitoring blood glucose and dosing devices
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:
Reduced Certification Time & Costs for Medical Submissions
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.
- FDA 510(k) class III medical device submissions
- IEC 62304 class C certification
- Independently assessed by TÜV SÜD for IEC 62304 Class C compliance
- No re-testing required
- Matthias Hölzer-Klüpfel, Independent Consultant & Co-Founder of International Certified Professional for Medical Software Board e.V.
Popular SafeRTOS Medical Platforms
- ST Microelectronics - STM32
- Texas Instruments - Hercules
- Texas Instruments - Tiva
- Freescale - Kinetis
- Freescale - i.MX
- Freescale - MPC
- NXP - LPC
- Renesas - RX
- Xilinx - Zynq
21 CFR 820 Medical Design History File
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:
- User Manual
- Safety Manual
- Development Plan
- Safety Management Plan
- Configuration Management Plan
- Test Plan
- HAZOP reports
- API Usage review
- HAZOPS Report for MPU
- MPU API Usage Safety Review
- Investigation arising from HAZOPS
- Tools Register
- EN 62304 & ISO 14791 Compliance Matrix
- Customer Requirements Specifications
- Software Requirements Specifications
- Architectural Software Design Documents
- Detailed Software Design Documents
- Product Variant Software Design Document
- Build Procedure
- Test Harness Build Procedure
- Code Verification Test Description
- Integration Verification Test Description
- System Verification Test Description
- Validation Test Description
- Software Test Reports
- Test Logs
Case Study: The world’s first ‘Warmed Liver’ transplant was carried out successfully, using technology devised by OrganOx with SAFERTOS at its core.
ISO 14971 Risk Management for Medical Devices
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.
Mixed Safety Integrity Levels (SILs)
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 in Multicore Medical Devices
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.
WHIS as your Trusted Partner for Medical Device Software Development
WITTENSTEIN high integrity systems are first and foremost a safety systems company. For safety critical developments, WHIS uses an ISO 9001:2015 Quality Management System, certified by Lloyds Register LRQA UK (since 2007) as appropriate for:
Lloyds Register LRQA UK
Beyond SAFERTOS for Medical Devices
- SAFERTOS CORE: for medical devices that only need to consider safety and don’t require full certification.
- Safety Component: bring greater robustness to safety critical medical designs. WHIS Safety components are available with a Design History File supporting certification to medical standards.
- Networking and Data Storage solutions: available tightly integrated with SAFERTOS using the Task Separation and Isolation functionality.
- Board Support Packages and Drivers: delivered either as commercial grade components, or with a Design History File supporting medical submissions and certifications.
- Training: maximise the use of your RTOS and middleware components, and increase development proficiency by attending one of our comprehensive training courses.
- Peer review services: sometimes just a few hours of consultancy to review a preliminary medical design, and check the approach being taken is correct, can deliver significant benefits to the outcome of a project.
- Consultancy services: designed to support our medical device customers, allowing us to share our knowledge and experience of medical device development to help optimise the final design, improve the design processes and smooth the route to medical device certification.