Software used in the quality management system shall be validated prior to its initial use and revalidation shall also be one in case of changes in such software or its application.

For software used for quality management system, to validate such software, one standard is available – ISO/TR 80002-2:2017 Medical Device Software – Part 2: Validation of Software for Medical Device Quality Systems.

This standard helps with software used in the quality management system, software used in production and service provision and software used for the monitoring and measurements of requirements.

As per ISO 13485:2016, if software is intended by the manufacture to be used, alone or in combination, for human beings, for one or more of the specific medical purpose. Software consists of information and which is generally intangible and can be in the form of approaches, transactions or procedures. Software used in any process during the manufacturing of the medical device or used as an application, it has to be validated.

Software Validation of the software which is and embedded or integral part of medical device or software is itself a medical device, has to be conducted. This can be done with the help of standard IEC 62304. Classification of software, life-cycle development life cycle, maintenance of software and most importantly, establishing the safety and effectiveness of a medical device containing software requirements of knowledge of what the software is intended do and the usage of software fulfils those intentions without causing any unacceptable risks.

Relationship of key Medical Device Standards to IEC 62304

Medical device management standards such as ISO 13485 and ISO 14971 provide a management environment that lays a foundation for an organization to develop products. Safety standards such as IEC 60601-1 and IEC 61010-1 give specific direction for creating safe Medical Devices.

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