Ads
related to: iso 13485 software validation example code
Search results
Results From The WOW.Com Content Network
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
Software validation checks that the software product satisfies or fits the intended use (high-level checking), i.e., the software meets the user requirements, not as specification artifacts or as needs of those who will operate the software only; but, as the needs of all the stakeholders (such as users, operators, administrators, managers ...
ISO 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to have a quality system that will comply with MDD 93/42/EEC and the MDR.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices.
The aim of software dynamic verification is to find the errors introduced by an activity (for example, having a medical software to analyze bio-chemical data); or by the repetitive performance of one or more activities (such as a stress test for a web server, i.e. check if the current product of the activity is as correct as it was at the ...
A RS can contain both written and graphical (models) information if necessary. Example: Software requirements specification (SRS). Requirements validation – Checking that the documented requirements and models are consistent and meet the stakeholder's needs. Only if the final draft passes the validation process, the RS becomes official.
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.