ISO/TR 80002-2:2017 pdf free.Medical device software — Part 2: Validation of software for medical device quality systems.
This document has been developed to assist readers in determining appropriate activities for the validation of process software used in medical device quality systems using a risk-based approach that applies critical thinking.
This includes software used in the quality management system, software used in production and service provision, and software used for the monitoring and measurement of requirements, as required by ISO 13485:2016:4.1.6,7.5.6 and 7.6.
This document is the result of an effort to bring together experience from medical device industry personnel who deal with performing this type of software validation and who are tasked with establishing auditable documentation. The document has been developed with certain questions and problems in mind that we all go through when faced with validating process software used in medical device quality systems such as the following: What has to be done? How much is enough? How is risk analysis involved? After much discussion, it has been concluded that in every case, a set of activities (i.e the tools from a toolbox) was identified to provide a level of confidence in the ability of the software to perform according to its intended use. However, the list of activities varied depending on factors including, among others, the complexity of the software, the risk of harm involved and the pedigree (e.g. quality, stability) of vendor-supplied software.
The intention of this document is to help stakeholders, including manufacturers, auditors and regulators, to understand and apply the requirement for validation of software included in ISO 13485:2016, 4.1.6,7.5.6 and 7.6.
ISO/TR 80002-2 applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.
ISO/TR 80002-2 applies to
– software used in the quality management system,
– software used in production and service provision, and
– software used for the monitoring and measurement of requirements.
It does not apply to
– software used as a component, part or accessory of a medical device, or
– software that is itself a medical device.