Effective verification and validation are central to medical device software development and are essential for regulatory approval. Although guidance is available in multiple standards in the medical device software domain, it is difficult for the manufacturer to implement as there is no consolidated view of this information. Likewise, the standards and guidance documents do not consider proces...

The increasing use of software within measurement systems implies that the validation of such software must be considered. This Guide addresses the validation both from the perspective of the user and the supplier. The complete Guide consists of a Management Overview and a Technical Application together with consideration of its use within safety systems. Version 2.1 Part I Management Aspects o...

Validation is a tool of quality assurance which provides confirmation of the quality in equipment system, manufacturing processes, software and testing methods. Validation assures the products with predetermined quality characteristics and attributes can be reproduced consistently/reproducibly with in the established limits of the manufacturing process operation at the manufacturing site. Valid...

Medical devices are nowadays more and more software dependent, and software malfunctioning can lead to injuries or death for patients. Several standards have been proposed for the development and the validation of medical devices, but they establish general guidelines on the use of common software engineering activities without any indication regarding methods and techniques to assure safety an...

This paper describes a hybrid simulation environment, interfaced to an adjustable autonomous software architecture, for validation and evaluation of advanced designs using dynamic interactive scenarios. The simulator provides support for "real-time" evaluation of adjustable autonomy strategies. In such evaluations, control actions by the operator interact with hardware events, including device ...

1. General aspects of software engineering in agricultural machines 2. Software applications in tractors – present overview 2.1.Basic control functions 2.2.Human Machine Interface 2.3.Automatic functions 2.4.Data Management 2.5.Service and Support 3. Economical requirements for software in agricultural machines 3.1.Challenges for software design 3.2.Strategies and principles for software design...

• Software requirements definition and validation • Domain-specific modeling and architectures • Software reuse strategies and techniques • CASE tool integration and life cycle support • Cleanroom software engineering methods and tools • Software process modeling and assessment • Empirical studies of tool and method effectiveness • Formal methods for systems development • Intelligent software a...

As modern software systems tend to be more and more distributed, the design for such systems becomes very complicated. Design validation for distributed software systems is particularly difficult. Not only must a suitable design representation first be obtained, but automatic analysis tools have to be developed to validate essential design decisions and their impact on the resulting software. I...

When errors in software modelling activities propagate to later phases of software development lifecycle, they become costlier to fix and lower the quality of the final product. Early validation of software models can prevent rework and incorrect development non-compliant with client’s specification. In this paper we advocate the use of ontologies to validate and improve the quality of software...

The benefits of effective verification and validation activities in the medical device domain include increased usability and reliability, decreased failure rate and recalls and reduced risks to patients and users. Though there is guidance on verification and validation in multiple standards in the medical device domain, these are difficult for the manufacturer to implement, as there is no cons...