Designers of medical devices have many issues to consider than the developers of other types of equipment. The devices are often complex, must be used by a variety of users (possibly including the patient), have complex communication requirements, and must safeguard patient confidential data. While the primary consideration is safety, the device must also achieve its therapeutic goals while minimizing danger to the patient and those who interact with the device. These safety considerations are more in-depth than most “safe” devices for industry since the graphics to give the providers the information they need are complex, and the consequences of issues may be fatal. So governments have built up regulatory infrastructure (such as within the Food and Drug Administration in the United States) that will review and approve the device before it may be marketed and used for its intended purpose.
Product Safety Software
Embedded Software that Enables Product Safety
Product Safety Software
Designers of medical devices have many issues to consider than the developers of other types of equipment. The devices are often complex, must be used by a variety of users (possibly including the patient), have complex communication requirements, and must safeguard patient confidential data. While the primary consideration is safety, the device must also achieve its therapeutic goals while minimizing danger to the patient and those who interact with the device. These safety considerations are more in-depth than most “safe” devices for industry since the graphics to give the providers the information they need are complex, and the consequences of issues may be fatal. So governments have built up regulatory infrastructure (such as within the Food and Drug Administration in the United States) that will review and approve the device before it may be marketed and used for its intended purpose.
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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