Method using iso software engeneering

Depending on the items present in the backlog eg a brand-new use scenario , it is also possible that you have to update the use specification and the list of primary operating functions, during an iteration.

You may base your formative evaluation on the use of these personas. With the role of end-user proxy for the team, the product owner is responsible for the formative evaluation. You can do the formative evaluation during the demonstration of the software at the end of the iteration. Depending on the results of the formative evaluation, new items related to the user-interface may be added to the backlog and implemented in a further iteration.

The summative evaluation is placed after the verification phase of the agile software development process. Incremental summative evaluation may be performed with intermediate releases. The user-interface is subject to changes in a further intermediate release, invalidating the conclusions of an incremental summative evaluation. I hope you have a better understanding on how to implement IEC in you software development process.

Remember that I'm in software above all, human factors engineering isn't my background. Congratulations and hate comments are welcome! Edit: Templates You will also find in the templates repository page , two templates useful to generate records of your usability engineering process:.

That was really useful, thx a lot. You explained the human, knowhow side of doing it, that others don't. Name or nickname :. Email address :. Website optional :. Comment :. This post's comments feed. Go to my Linkedin profile.

Home Templates Guidances Contact me. Usability engineering plan Write what you do, do what you write. The usability engineering plan describes the following topics: Input data review, Definition of use specification, Link with risk management, User interface specification, Formative evaluation protocol, Formative evaluation report, Design review s , Summative evaluation protocol, Summative evaluation report, Usability validation.

Usability input data Usability input data is a subset of design input data. Depending on the context of the project, they can contain: Statements of work, User requirements collected by sales personnel, product managers …, Data from previous projects, Feedback from users on previous versions of medical devices, Documentation on similar medical devices, Specific standards, like IEC Home use of electromedical devices, Regulatory requirements, like IFU or labeling.

Preparing the use specification The use specification is a high-level statement, which contains information necessary to identify: the user groups which are going to be subject of the usability engineering process, the use environment in which the device is going to be used, the medical indications which are needed to be explored further. The use specification shall include the: Intended medical indication; Intended patient population; Intended part of the body or type of tissue applied to or interacted with; Intended user profiles; Use environment; and Operating principle.

Preparing the use specification can make use of various methods, for example: Contextual enquiries in the user's workplace, Interview and survey techniques, Expert reviews, Advisory panel reviews.

This method is the simplest to implement once again if you can afford not to use other methods :- The use specification is recorded in the usability management file. Analysis The usability engineering process is performed in parallel to the ISO risk management process. Identifying characteristics for safety This step sounds clearly like risk management. It consists in identifying: The primary operating functions in the device, The use scenarios, The possible use errors. Identifying hazardous phenomena and hazardous situations This step consists in identifying the hazardous phenomena and hazardous situations ditto.

They are identified with data coming from: The use specification, Data from comparable devices or previous generations of the device, User errors identified in the previous step. Identifying and describing hazard-related use scenarios This step is once again risk analysis: the hazardous phenomena, the sequence of events, and the hazards, resulting of the human factors are identified.

Selecting hazards-related scenarios for summative evaluation It is not required to submit all hazard-related scenarios to the summative evaluation. Identifying mitigation actions and documenting the user interface specification The risks related to the use scenarios are then evaluated according the risk management plan severity, frequency, and possibly detectability if you included that parameter in you risk management plan , and mitigation actions are identified, by following the risk management process.

Design and Formative Evaluation The formative evaluation is performed during the design phase. Summative evaluation The summative evaluation is performed at the end of the design phase. Application to agile methods The steps described above can be disseminated in the increments of an agile development process.

Iterations and usability engineering The next steps of the usability engineering process are performed during iterations, as shown in the following diagram and explained in the next subsections. Summative evaluation The summative evaluation is placed after the verification phase of the agile software development process. This standard deals with software packages delivered to the client. A methodology for establishing quality requirements, identifying, implementing, analyzing, and validating the process, and product of software quality metrics.

Arnab Chakraborty. Zach Miller. John Shea. Daniel IT. Previous Page. Next Page. Software Engineering Tutorial delivers basic and advanced concepts of Software Engineering. Software Engineering Tutorial is designed to help beginners and professionals both. The term software engineering is the product of two words, software , and engineering.

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