Regulators of iec 62304 have put a lot of energy into normalizing how to handle soups software of unknown provenance for software of classes b and c software that is in a position to potentially harm people in a nonbenign way. Regulators of iec 62304 have put a lot of energy into normalizing how to handle soups software of unknown provenance for software of. Software of unknown provenance soup formal methods are best when applied at the beginning embedded systems may rely on software with no source code or with source code contributed by unknown authors even when you have source code, compiler can introduce errors new software might use existing libraries of unknown provenance. Software that is already developed and generally available and.
At certified soup, we provide certified versions of popular software of unknown provenance soup and offtheshelf ots software. The standard spells out a riskbased decision model on when the use of soup is acceptable, and defines testing requirements for soup to support a rationale on why such software should be used. According to iec 62304 terminology, 3rd party software are software of unknown provenance, aka soup. When cots is not soup commercial offtheshelf software in. Soup stands for software of unknown or uncertain pedigree or provenance, and is a term often used in the context of safetycritical and safetyinvolved.
Soup is defined as software of unknown pedigree somewhat frequently. Soup is software that is actually incorporated into the medical device e. In some instances this may be legacy custom software, but these days it probably. Problems while documenting the soups used for the software we. Im working on the implementation of an iec 62304 compliant development process in our company and i have a question considering soup software of unknown provenance. Soup software of unknown provenance johner institute. Iec 62304, are software frameworks springjeeangularreact. Soup is an acronym for software of unknown provenance. The iec 62304 standard calls out certain cautions on using software, particularly soup software of unknown pedigree or provenance. Proving security properties in software of unknown provenance. Software of unknown pedigree how is software of unknown. The iec 62304 defines a soup as a software component, which is already developed and widely available, and that has not been designed to be integrated into the medical device also known as offtheshelf software, or previously developed software, not available for the adequate records. To follow up on lei zongs post last week about threat assessments, a specific area of concern that is overlooked is related to vulnerabilities of software of unknown provenance soup items. Developing medical device software to iec 62304 mddi online.
Soup abbreviation stands for software of unknown provenance. How to select ots software based on software engineering principles and common sense. What is the abbreviation for software of unknown provenance. Using software of unknown provenance in medical device.
Iec 62304 software of unknown provenance soup iec 62304 defines software that is already developed and generally available as software of unknown provenance, or soup. Software component that is already developed and widely available, and that has not been developed, to be integrated into the medical device also known as offtheshelf software, or previously developed software for which adequate records of the development process are not available. For this application we will use different opensource libraries on the backend as well as on the frontend. Overview of software development processes and activities source. Our goal is the develop a web application in the future. Software of unknown provenance soup, is formally defined within iec 62304. Although i dont have a solid answer to the question. It is very unlikely that you can determine how this software was developed, so its up to you to validate that it does what its supposed to do. Meanings of soup in english as mentioned above, soup is used as an acronym in text messages to represent software of unknown provenance. Oct 20, 2016 fda and industry have provided some guidance for using soup software of unknown pedigree or provenance. Software lifecycle processes defines a software item that has already been developed, is generally available and that was not developed for the purpose of being incorporated into a medical device as soup software of unknown provenance. Otssoup software validation strategies bob on medical. Meeting medical device standards with offtheshelf software.
Software of unknown provenance soup, is formally defined within iec 62304 medical device software software life cycle processes, but generally understood as off the shelf software items which are used in a medical device we will discuss the formal definition in a future blog. If not, then the product is essentially soup keep reading. All of these fall under the category of soup software of unknown provenance or pedigree. Software of unknown provenance how is software of unknown.
Software developed and maintained with respect to iec 62304 requirements or with respect to medical devices regulations are not soup. Something you buy or open source code that is of complete or somewhat unknown quality because you dont have access to the qualifying materials e. In this short article, we consider ways of dealing with soup. May 22, 2018 soup stands for software of unknown or uncertain pedigree or provenance, and is a term often used in the context of safetycritical and safetyinvolved systems such as medical software. Common types of ots software used by medical devices companies. Jul 25, 2017 hey mum, uoup is the acronym for user interface of unknown provenance. Software of unknown provenance an introduction team consulting. May 17, 20 according to iec 62304 terminology, 3rd party software are software of unknown provenance, aka soup.
Although software of unknown pedigree soup is a wellknown concept and software supply chain risk management is already a reality in medical device software development, till recently risk management has often ignored the risk of thirdparty components, without sufficient technology to analyze and understand the impact of this software. The standard does not stop at the definition though, it also identifies those steps in the. The medical device software standard, iec 62304, defines soup and describes ways to manage soup in your product. Jan 08, 2017 regulators of iec 62304 have put a lot of energy into normalizing how to handle soups software of unknown provenance for software of classes b and c software that is in a position to potentially harm people in a nonbenign way. Soup stands for software of unknown or uncertain pedigree or provenance, and is a term often used in the context of safetycritical and safetyinvolved systems such as medical software. Understanding uoup user interface of unknown provenance. Two fda guidances which dont use the soup acronym but still apply are fdas offtheshelf software use in medical devices and of course fdas general principles of software validation. This page is about the meanings of the acronymabbreviationshorthand soup in the computing field in general and in the software terminology in particular. Fda software guidances and the iec 62304 software standard.
Soup, software of unknown provenance, is a way of identifying components that may not have been developed according to medical device standards. Soup is defined as software of unknown provenance frequently. Part 1 because every good software starts with soup. Soup is software that has not been developed with a known software development process or methodology, or which has unknown or no safetyrelated properties. The fda has been working to change that by requiring a more systematic approach. Sep 12, 2011 soup is software that is actually incorporated into the medical device e. Software of unknown pedigree aka software of uncertain provenance, aka soup has been a term used primarily in scenarios where software hardwarefirmware governs a system that if breached or malfunctioning could have explicit implications on consumer safety.
This page is all about the acronym of soup and its meanings as software of unknown provenance. As mentioned above, soup is used as an acronym in text messages to represent software of unknown provenance. Unfortunately, were not talking about a bowl of chicken noodle goodness. Software that is already developed and generally available and that has. Software item a software component or module a part of a complete software system software unit the smallest software item. Nov 10, 2017 wow, that soup sure covers a can of worms. Reducing the risk of the software supply chain in medical devices. Software item that is already developed and generally available and that has not been developed for the purpose of being incorporated into the medical device also known as off theshelf software or software item previously developed for. Jun 01, 2010 software of unknown provenance, or soup, is any code tools or source code that does not have formal documentation or was developed by a third party and has no evidence as to the controls on the development process. Offtheshelf ots software is commonly being considered for incorporation into medical devices as the use of generalpurpose computer hardware becomes more prevalent. Understanding the fda guideline on offtheshelf software. This code by definition is deemed to be capable of producing faults.
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