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Fritzing is an open-source hardware initiative to support designers, artists, researchers and hobbyists to work creatively with interactive electronics. Fritzing is essentially an Electronic Design Automation software with a low entry barrier, suited for the needs of designers and artists. Physical prototyping tools have come a long way and already allow non-engineers to quickly turn their ideas into functional interactive prototypes.
Please do not link images directly to the site, download and store them on your web server. The images displayed here cannot be used for any commercial purpose, without written consent of the original author. Software is playing an expanding role in modern medical devices, raising the question of how developers, regulators, medical professionals, and patients can be confident in the devices' reliability, safety, and security. We are creating a software tool, a community website and services in the spirit of Processing and Arduino, fostering an ecosystem that allows users to document their prototypes, share them with others, teach electronics in a classroom, and layout and manufacture professional pcbs.
It uses the metaphor of the breadboard, so that it is easy to transfer your hardware sketch to the software. You might use the images on you website for educational, recommendation, and demonstration purposes only by including a mandatory reference link below. You may not actively redistribute or sublicense any of our graphics or digital media under any circumstances. Software- related errors in medical equipment have caused people's deaths in the past, so the issue is not simply theoretical. There are many LIS system and devices working on software application to monitor and diagnose diseases quite easily.
From there it is possible to create PCB layouts for turning it into a robust PCB yourself or by help of a manufacturer. This is where Fritzing comes in: It allows the designer to move to the next stage and create a finished PCB of your individual circuit in the desired shape. The digital media may not be used in any online or other electronic distribution system, such as an online gallery or collection of graphics.
Device manufacturers need to provide safety assurance for complex software that is being developed in a competitive environment where price and time-to-market are critical factors. However, it is true that there are many concerns about safety and security of such devices still occur that should be sort out before any inconsequence. This makes the circuit robust and is the basis for a permanent installation or even batch production of your project. Further, security issues that previously were not a major concern now need to be anticipated and handled. This includes how some recent Food and Drug Administration (FDA) regulations are dealing with such issues, and how programming language and support tool technology can help.


On the other hand, one person dying from an insulin overdose caused by faulty infusion pump software does not get the same attention. But historically the requirements for certification in the medical industry have not been as strict as in domains such as commercial avionics. Medical devices often need to be operated by end users (patients) who have no formal training. That places a higher demand on the design of the user interface and the need for hardware- or software-enforced checks on inputs or outputs.
In contrast, a medical device manufacturer tends to react more quickly to hardware improvements that will offer a competitive advantage in terms of performance or functionality.
But more fundamentally, a detailed accident analysis cited shortcomings in the development and verification process, including inadequate software engineering practices. Analyses of MDRs \\[Medical Device Reportings\\] have revealed device problems that appear to be a result of faulty design. Between January 1, 2005 and December 31, 2009, FDA received over 56,000 MDRs associated with the use of infusion pumps.
Of these reports, approximately 1% were reported as deaths, 34% were reported as serious injuries, and 62% were reported as malfunctions. FDA has structured this guidance document to address these device problems prior to clearance of the premarket notification and in the postmarket context. It is not intrinsically more or less expensive than other methods, but the key is to apply it early in the development process so that potential hazards can be avoided before they get into the product. Building an assurance case after the fact is possible but will require understanding or reverse engineering the requirements and the design, and that is a difficult and costly process. It also tends to emphasize testing, versus say formal methods, as the main way to verify that software meets its requirements. Since dependability cannot be guaranteed from an assessment of the software product, it is necessary to have assurance on its development process. Although there have been some close calls, there has never been a fatal aircraft accident that has been attributed to DO-178B-certified software. Its relationship with safety is therefore more direct than with the process-based approach. The connectivity raises obvious security questions; how to ensure that the equipment, the software, and the data are protected from threats to the needed confidentiality, integrity, and availability. In a sense, it could be treated as a special category of safety (in order to be safe, a system has to be secure) but security issues have some inherent differences from safety issues. For example, with safety one may take a probabilistic approach to device failure based on hardware characteristics, but with security one must assume that an adversary who knows about a vulnerability will exploit it. Languages differ with respect to their susceptibility to vulnerabilities, and the language choice affects the ease or difficulty of achieving safety certification.


The language should not have features whose effect is unspecified or implementation dependent. Such features interfere with portability (for example the program might have a different effect when compiled with a different compiler) and may introduce security vulnerabilities. It has a proven track record in both safety and security, and is highly analyzable, due to the language restrictions and to Ada's ability to specify subranges on scalar data. This is intended for applications that need to be certified at the highest levels and may be attractive to a developer who has settled on Java for other parts of the system. However, the safety-critical Java effort is not yet complete, and it remains to be seen whether its approach to memory management without automatic storage reclamation is practical. A language technology such as SPARK offers the most technical advantages, while options, such as MISRA C and MISRA C++, have larger user and vendor communities. Feed the source code into the tool, have it detect potential vulnerabilities, and then make the appropriate repair.
So in a sense, a static analyzer that detects, say, a potential buffer overflow, is coming in too late.
It's preferable (and less expensive) if the error is detected at the outset, before the bug settles into the delivered code.
And here the language makes a difference, as was pointed out in the answer to the previous question. A language with strong type checking will prevent a pointer from being treated as an integer. A language with run-time checking will throw an exception if an array index is out of range. For example, an existing system might need to be deployed in a networked environment and thus has to be analyzed for potential vulnerabilities. There are also several practicalities that need to be taken into account: Soundness: Does the tool report all errors in the class of bugs that it is looking for? If a tool is not sound then it must be complemented with some other analysis in order to ensure that all errors are detected. If a tool is not precise, then developers can easily overlook real errors given the large number of false alarms.



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