Whois & Analysis for matrixreq.com

Agile software development describes a set of principles for software development under which requirements and solutions evolve through the collaborative effort of self-organizing cross-functional teams.

It advocates adaptive planning, evolutionary development, early delivery, and continuous improvement, and it encourages rapid and flexible response to change.

These principles support the definition and continuing evolution of many software development methods.

A medical device is any instrument, 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:

Traceability is the ability to verify the history, location, or application of an item by means of documented recorded identification.

A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.

It is aligned with an organization's purpose and strategic direction (ISO9001:2015).

It is expressed as the organizational goals and aspirations, policies, processes, documented information and resources needed to implement and maintain it.

Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling.

By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continuous improvement cycle.

In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality is increasingly tied to these factors.

Of QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both, and deals with quality and sustainability and their integration.

In product development and process optimization, a requirement is a singular documented physical and functional need that a particular design, product or process must be able to perform.

It is most commonly used in a formal sense in systems engineering, software engineering, or enterprise engineering.

It is a statement that identifies a necessary attribute, capability, characteristic, or quality of a system for it to have value and utility to a customer, organization, internal user, or other stakeholder.