The topic of software usage in ISO 13485:2016 (the Quality Management System for Medical Devices industry) often raises tough questions that slow down the implementation of the management system. 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.In order to facilitate this issue, the ISO/TR 80002-2:2017 was developed to clarify and apply the requirements for validation of the application of computer software used in quality management systems, particularly in clauses 4.1.6, 7.5.6 and 7.6. The ISO/TR 80002-2 applies to any software used in the design, testing, manufacturing, labelling, packaging, distribution of a medical device. When properly followed, this standard will address the typical concerns of “What needs to be done?” and “How is risk analysis involved in the process?”
While a software does not need to be certified with ISO/TR 80002, Stendard has decided to be the first few companies in the region to get its cloud-based software assessed against the standard, and it has received a Certificate of Compliance by TÜV Rheinland recently. The usage of such software can help companies skip the conventional time-consuming manual documentation process implementing ISO 13485, which is already halfway in the transition timeline to the new revision.
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