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20 relations: CISQ, Gold standard (test), IEC 60601, International Electrotechnical Commission, International standard, ISO 13485, ISO 14971, ISO 9000, List of International Electrotechnical Commission standards, Market (economics), Medical device, Medical software, Quality management system, Regulatory compliance, Risk management, Software of unknown pedigree, Software quality, Software release life cycle, Software safety classification, Time-triggered architecture.
CISQ
The Consortium for IT Software Quality (CISQ) is an IT industry leadership group that develops international standards for automating the measurement of software size and software structural quality from system source code.
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Gold standard (test)
In medicine and statistics, gold standard test is usually diagnostic test or benchmark that is the best available under reasonable conditions.
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IEC 60601
IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission.
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International Electrotechnical Commission
The International Electrotechnical Commission (IEC; in French: Commission électrotechnique internationale) is an international standards organization that prepares and publishes International Standards for all electrical, electronic and related technologies – collectively known as "electrotechnology".
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International standard
International standards are standards developed by international standards organizations.
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ISO 13485
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
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ISO 14971
ISO 14971 is an ISO standard for the application of risk management to medical devices.
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ISO 9000
The ISO 9000 family of quality management systems standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.
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List of International Electrotechnical Commission standards
This is an incomplete list of standards published by the International Electrotechnical Commission (IEC).
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Market (economics)
A market is one of the many varieties of systems, institutions, procedures, social relations and infrastructures whereby parties engage in exchange.
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Medical device
A medical device is any apparatus, appliance, software, material, or other article—whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application—intended by the manufacturer to be used for human beings for the purpose of.
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Medical software
Medical software is any software item or system used within a medical context, such as.
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Quality management system
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.
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Regulatory compliance
In general, compliance means conforming to a rule, such as a specification, policy, standard or law.
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Risk management
Risk management is the identification, evaluation, and prioritization of risks (defined in ISO 31000 as the effect of uncertainty on objectives) followed by coordinator and economical application of resources to minimize, monitor, and control the probability or impact of unfortunate events or to maximize the realization of opportunities.
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Software of unknown pedigree
SOUP stands for software of unknown (or uncertain) pedigree (or provenance), and is a term often used in the context of safety-critical and safety-involved systems such as medical software.
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Software quality
In the context of software engineering, software quality refers to two related but distinct notions that exist wherever quality is defined in a business context.
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Software release life cycle
A software release life cycle is the sum of the stages of development and maturity for a piece of computer software: ranging from its initial development to its eventual release, and including updated versions of the released version to help improve software or fix software bugs still present in the software.
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Software safety classification
Software classification is based on potential for hazard(s) that could cause injury to the user or patient.
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Time-triggered architecture
Time-triggered architecture (abbreviated as TTA), also known as a time-triggered system, is a computer system that executes one or more sets of tasks according to a pre-determined and set task schedule.
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