Designers of devices that could harm people if they fail in some manner, or even if they are 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. Below is additional safety considerations for different industries such as Aerospace, Automotive, Industrial, and Medical.
Product Safety Software
Embedded Software that Enables Product Safety
Product Safety Software
Designers of devices that could harm people if they fail in some manner, or even if they are 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. Below is additional safety considerations for different industries such as Aerospace, Automotive, Industrial, and Medical.
Embedded Products
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.
Pre-Certified Software for Safe Devices
Third party software components that might be used in a medical device are not normally developed to medical software standards, and the use of this software must be justified from a risk analysis perspective. However, Mentor Embedded can provide proprietary software products such as Nucleus SafetyCert pre-certified to the medical software safety standard IEC 62304, along with an evidence package that satisfies the requirements of medical functional safety. On top of these products, Mentor Embedded can provide services and support to target this software to a medical device, and limit the regulatory headaches that using off-the-shelf software can bring to medical device developers.
Regulatory Submissions, Approval & 3rd Party Software
In the United States, any medical device requires Premarket Notification Submissions (and approvals) through the FDA’a 510(k) Submission Process. As part of the 510(k) submission package and subsequent review, the FDA reviews the patient risks and medical benefits of the device before it may be allowed to be released to the public. This review is all-encompassing, including safety, security and functionality components of the type of medical device being reviewed. The FDA puts a high level of scrutiny on any 3rd party software to be used in the device, both from safety and security standpoints. As a trusted supplier to medical device manufacturers, Mentor Embedded has the products, services and expertise to support these goals and to assist the manufacturer through this exacting process.
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Resource
IEC 62304: Medical Device Life Cycles Requirements
Medical device software - Software life cycle processes
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CVE
Common Vulnerabilities and Exposures Database
Resource
IEC 61508: Functional Safety of Electrical Systems
Ensuring safety is one of the key principles guiding the work of the IEC while recognizing that zero risk is not possible