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Designers of devices that could harm people if they fail in some manner, or even if used incorrectly, have many more issues to consider than the developers of other types of equipment. The devices are often complex, may be used by a variety of users, have complex communication requirements, and in some cases must safeguard confidential data.
While the primary consideration is safety, the device must also achieve its functional goals while minimizing danger to the user, others who interact with the device, and the environment. Industries, such as Aerospace, Automotive, Industrial, and Medical, have different product safety software requirements and certifications.
Designers of devices that could harm people if they fail in some manner, or even if used incorrectly, have many more issues to consider than the developers of other types of equipment. The devices are often complex, may be used by a variety of users, have complex communication requirements, and in some cases must safeguard confidential data.
While the primary consideration is safety, the device must also achieve its functional goals while minimizing danger to the user, others who interact with the device, and the environment. Industries, such as Aerospace, Automotive, Industrial, and Medical, have different product safety software requirements and certifications.
Siemens delivers embedded software solutions that enable device manufacturers to quickly design and build high quality connected devices, including those with rich user interfaces, cloud-based remote management, or requiring safety certification. Base technologies include Linux, the Nucleus real-time operating system, advanced multicore runtime and IoT enablement and development tools.
Designers of software intended to run in airborne systems have many things to consider that are different than designers of other safety systems. The highest level of safety is required. Governmental authorities regulate the systems associated with these devices and the software that runs on them.
Agencies like the FAA in the United States or the EASA in the European Union verify and rely on conformance to the DO-178C and related RTCA standards. Governmental authorities impose these standards on device manufacturers that intend to sell their equipment to aircraft manufacturers and other devices used to ensure civilian safety.
While the military and space industries do not require these stringent standards, they do recognize these and similar standards and often expect their suppliers to conform to these standards, as well.
As a trusted supplier to automotive OEM, Tier 1 and 2 suppliers, Siemens Embedded has the products, services, and expertise to supply certified and high-quality open-source software, backed with the necessary evidence, to be deployed in these highly demanding systems.
While certain aspects of industry have defined specific standards for governance (for example, nuclear power), most suppliers for manufacturing have settled on the standard IEC 61508 (Functional Safety of Electrical/Electronic/Programmable Electronic Safety-related Systems) to manage the implementation of complex safety requirements. IEC 61508 guides all aspects of equipment development, including software developed by OEMs and suppliers and third-party and open-source software. This guidance is comprehensive and can be challenging to manage when third-party software is involved.
As a trusted supplier to industrial OEM, Tier 1, and 2 suppliers, Siemens Embedded has the products, services, and expertise to supply safety-certified products and high-quality open-source software, backed with the necessary evidence to be deployed in these highly demanding systems.
Designers of medical devices have many more issues to consider than developers of other types of safety equipment. Medical devices are complex. In addition to various types of users (possibly including the patient), medical devices have complex communication requirements, including safeguarding confidential patient data. Medical devices must achieve their therapeutic goals while minimizing risks to patients and those who interact with the devices.
More in-depth safety considerations are required since these devices monitor or treat the health of patients; therefore, any issues can directly impact a person’s safety.
For example, device graphics that care providers need are complex, so governments have built regulatory infrastructures (such as the U.S. Food and Drug Administration) to review and approve devices before they are marketed and used for their intended purposes.
Third party software components that might be used in a safe device are not normally developed to the industry specific software safety standards, and the use of this software must be justified from a risk analysis perspective. Siemens Embedded provides proprietary software products such as Nucleus SafetyCert pre-certified to industry safety standards such as IEC 62304 or ISO 26262, or that fully satisfies the requirements of DO-178C. On top of these products, Siemens Embedded provides services and support to target this software to your device, and limit the regulatory headaches that using off-the-shelf software can bring to safe device developers.
When designing and developing safe devices, there will usually be a regulatory authority that the manufacturer will work with to approve their device for use. This could be a private enterprise like Underwriters Laboratories or TUV Süd (that may or may not also be working with regulators), or it can be a part of a governmental agency like a Designated Engineering Representative from the FAA for aeronautic applications; each industry has its own specific requirements. All of these regulators put a high level of scrutiny on any 3rd party software to be used in the device. To learn more about the specific requirements of each industry, and how Siemens Embedded can help, click on the industry specific pages such as Aerospace, Automotive, Industrial, and Medical.
Common Vulnerabilities and Exposures Database
Ensuring safety is one of the key principles guiding the work of the IEC while recognizing that zero risk is not possible
Siemens Embedded Software products improve design efficiency and reduces business costs